[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"New York State Psychiatric Institute\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":602},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,24,0,[8,48,70,93,125,154,176,197,220,248,269,291,317,335,360,382,414,431,461,492,515,541,568,580],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100054230","phase-4-exercise-and-olanzapine-samidorphan-100054230",false,"NCT06740890","Exercise and Olanzapine-samidorphan","A Proof of Concept Study of Time Limited Exercise Plus Olanzapine-samidorphan for the Prevention of Early Weight Gain","Inclusion Criteria:\n\n1. Age between 18-65, inclusive at Visit 1.\n2. DSM-V diagnosis of schizophrenia or schizoaffective or Bipolar I\u002FII\u002FNOS disorder at Visit 1.\n3. Body Mass Index (BMI) of 18.0-40.0 kg\u002Fm2, inclusive, at Visits 1 and 2.\n4. Willing to provide informed consent at Visit 1.\n5. Medically and psychiatrically stable for study participation at Visit 1.\n6. Responsive to an antipsychotic treatment (other than clozapine) in the past 5 years prior to Visit 1.\n7. Can benefit from participation in this study and has a reason to participate, such as inadequate efficacy on current treatment, side effects on current treatment, desire to start olanzapine-samidorphan or try structured exercise program (assessed at Visit 1).\n8. Maintained a stable body weight (change \\\u003C 5%) for at least 3 months prior to Visit 1.\n9. Willing to use qualified methods of contraception (listed in section 5.3) for the study duration (for women of childbearing potential only) (assessed at Visit 1 and Visit 2).\n\nExclusion Criteria:\n\n1. Positive drug screen for opioids, phencyclidine, amphetamine\u002F methamphetamine, or cocaine at Visit 1 or Visit 2.\n2. Diagnosis of moderate or severe substance use disorder, anorexia nervosa, bulimia, binge eating disorder or any other clinically significant eating disorder at Visit 1.\n3. EKG abnormality that is clinically significant including a QT interval \\> 450 msec for men and \\> 470 msec for women, as corrected by the Fridericia formula (QTcF) at Visit 1.\n4. Use of olanzapine+samidorphan for any reason in the last six months prior to Visit 1, any history of poor or inadequate response to treatment with olanzapine or no justifiable reason to expect improvement on olanzapine as assessed at Visit 1.\n5. Taken opioid agonists (e.g., codeine, oxycodone, tramadol, or morphine) within the 14 days prior to Visit 1 and\u002For anticipates a need to take opioid medication during the study period (e.g., planned surgery), or has taken opioid antagonists including naltrexone (any formulations) or naloxone within 60 days prior to Visit 1.\n6. Pregnant or breast feeding women. Women of child-bearing potential must have a negative serum beta-hCG pregnancy test at Visit 1 and a negative urine pregnancy test at Visit 2.\n7. Any clinically significant or unstable medical illness, condition, or disorder that is anticipated to potentially compromise subject safety on study medication or exercise, or adversely affect the evaluation of efficacy, including (but not necessarily limited to) the following (as assessed at Visit 1):\n\n   1. Clinically significant hypotension or hypertension not stabilized on medical therapy.\n   2. Unstable thyroid dysfunction in the past 6 months (e.g., hypothyroidism, hyperthyroidism, or thyroiditis that was untreated, or discovered and treatment was initiated within the 6 months prior to screening).\n   3. Personal or family history of neuroleptic malignant syndrome, has a history of clinically significant extrapyramidal symptoms when taking olanzapine, or has had clinically significant tardive dyskinesia.\n   4. Neurological conditions include the following:\n\n      * History of seizure disorder or a condition associated with seizures (except history of febrile seizures).\n      * History of brain tumor, subdural hematoma, stroke or any other clinically significant neurological condition within the 12 months prior to Visit 1.\n      * Head trauma with loss of consciousness within the 12 months prior to Visit 1.\n      * Active, acute or chronic CNS infection.\n   5. Cardiac condition that might confound study results, pose additional risk when administering the study drug or exercise regimen to the subject, or preclude successful completion of the study. Conditions include the following:\n\n      * Clinically significant cardiac arrhythmia, cardiomyopathy, a cardiac conduction defect, or a history of myocardial infarction or unstable angina within 6 months prior to Visit 1.\n8. Currently taking any contraindicated medications as per the approved labeling for Olz-Sam (see section 6.5 for details) at Visit 1 and Visit 2.\n9. Subjects with suicidal ideation with intent or plan (indicated by affirmative answers to items 4 or 5 of the Suicidal Ideation section of the baseline C-SSRS) in the 3 months prior to Visit 1 or current at Visit 2\n10. Inflammatory bowel disease or any other gastrointestinal disorder associated with weight loss at Visit 1.\n11. Joined a weight management program or had significant changes in diet or exercise regimen within 6 weeks prior to Visit 1 or plans to join a weight management program during the study as assessed at Visit 1.\n12. History of diabetes (assessed at Visit 1).\n13. Laboratory abnormality that would compromise the well-being of the subject, or any of the following specific laboratory results at Visit 1:\n\n    1. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) value \\> 2 times the upper limit of the laboratory normal reference range\n    2. Absolute neutrophil count (ANC) \\\u003C1.5 x 10\\^3 μL\n    3. Platelet count \\\u003C 75 x 10\\^3 uL\n    4. Serum creatinine \\> 1.5 mg\u002FdL\n    5. Dyslipidemia, defined for this study as total fasting cholesterol \\> 280 mg\u002FdL or fasting triglycerides \\> 500 mg\u002FdL\n    6. Hemoglobin A1c (HbA1c) \\> 6.0%\n    7. Fasting plasma glucose \\> 126 mg\u002FdL (7.0 mmol\u002FL)\n14. Is not fit for the trial in the opinion of the investigator at Visit 1 and Visit 2.","ALL","18 Years","65 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","This is a single site trial in 30 patients with schizophrenia, schizoaffective, or bipolar I\u002FII\u002FNOS disorder in which all participants will receive eight weeks of olanzapine and samidorphan (Olz\u002FSam) plus four weeks of aerobic exercise.",[27,28,29,30],"Schizophenia Disorder","Schizoaffective Disorder","Bipolar Disorder I or II","Bipolar Disorder NOS",[32,33,34],"Exercise","Antipsychotic induced weight gain","olanzapine-samidorphan","RECRUITING","2026-07-10",{"date":38,"type":39},"2026-07-13","ACTUAL",{"date":41,"type":39},"2025-06-26",{"date":43,"type":21},"2027-04",{"name":45,"class":46},"New York State Psychiatric Institute","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":55,"sex":16,"minAge":17,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":64,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":47},"100053217","phase-1-glutamatergic-mechanisms-aim2-100053217","NCT05401227","Glutamatergic Mechanisms: Aim2","Glutamatergic Mechanisms of Psychosis and Target Engagement: Aim2","Inclusion Criteria:\n\n1. Age between 18-55 at screen\n2. Medically healthy, as assessed by study physician at screen\n3. Capable of understanding the study procedures and able to provide informed consent\n4. Eligible men and women must agree to use a reliable method of birth control (See section 5.3) during the study. Women who are post-menopausal or otherwise not of childbearing potential are also eligible.\n5. Willing and reliable to participate in XT or placebo phase as an outpatient and\u002For agreeable to participate as an inpatient.\n\nExclusion Criteria:\n\n1. Current or past Axis I psychiatric history (including Substance Use Disorder\u002FAlcohol Use Disorder, with the exception of nicotine use disorder) as assessed at screen\n2. Positive urine toxicology or alcohol at screen\n3. History of recreational ketamine use, recreational PCP use, or an adverse reaction to ketamine. Participants who have participated in prior research ketamine studies will be eligible. Participants can have infusions not more frequently than biweekly, and not more than 1\u002Fmonth on average, therefore participants entering the study will need to wait one month if they had a single infusion and 6 weeks if they have had two closely spaced infusions.\n4. History of first-degree relative with schizophrenia\n5. Pregnancy or breast-feeding. This exclusion criterion applies only to females of child-bearing potential (not surgically sterilized and between menarche and 1 year postmenopausal). Must test negative for pregnancy at the time of screening based on a serum pregnancy test.\n6. History of violence, including any history of using a gun, knife, or other weapon with intent to harm someone, as well as more than one physical fight without a weapon after the age of 18 years old (not including fights that happen during sports competition).\n7. Presence or positive history of significant medical illness at screen, including:\n\n   * Contraindications to XT (urinary retention, moderate or severe hepatic impairment, gastric retention, untreated narrow-angle glaucoma, hypernasality)\n   * renal problems (GFR\\\u003C60)\n   * high blood pressure (defined as supine systolic blood pressure (SBP) \\> 140 or supine diastolic blood pressure (DBP) \\> 90)\n   * low blood pressure (defined as supine SBP \\\u003C 100, DBP \\\u003C 60)\n   * abnormal orthostatic blood pressure (change in mean arterial pressure \\[1\u002F3 systolic + 2\u002F3 diastolic\\] of \\> 20% between supine and standing blood pressures)\n   * clinically significant cardiac illness, as determined by the site physician\n   * clinically significant abnormal screening labs, as determined by the site physician\n8. Participants with suicidal ideation with intent or plan (indicated by affirmative answers to items 4 or 5 of the Suicidal Ideation section of the baseline C-SSRS) in the 6 months prior to screening or participants who represent a significant risk of suicide in the opinion of the investigator.\n9. Presence or positive history of neurological illness, including seizures, mental retardation or any other disease\u002Fprocedure\u002Faccident\u002Fintervention associated with significant injury to or malfunction of the central nervous system (CNS), or history of significant head injury.\n10. Any material in the body that is a contraindication for MRI procedures\n11. Currently taking any psychotropic medication, including antidepressant medications, benzodiazepines, antipsychotic medications, mood stabilizers, anti-epileptic medications, and stimulants. We will exclude any participant who requires treatment with any psychotropic medication from one of these classes.",true,"55 Years",{"count":58,"type":21},120,[60],"PHASE1","In the present study, 120 healthy volunteers (HV) will be randomized to one of three ketamine-induced pharmacoBOLD (phBOLD) arms: low, medium, and high. Within each ketamine arm, participants will be randomized to 4 days of \"study drug\" \\[TS-134 (1st 20 participants) or XT (remaining 100 participants)\\] or placebo in a 5:3 ratio (25 study drug:15 placebo per arm).\n\nDuring the study, each participant will undergo a Screening Period (up to 31 days), a 4-day Treatment Period, and a total of two phBOLD sessions: a first session at Baseline and a second session on Day 4 of the Treatment Period, conducted at least 7 days apart, and a follow up visit.",[63],"Healthy",{"date":38,"type":39},{"date":66,"type":39},"2022-10-15",{"date":68,"type":21},"2029-08",{"name":45,"class":46},{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":77,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":47},"100480895","scaling-up-e-connect-in-juvenile-probation-settings-100480895","NCT05541926","Scaling up e-Connect in Juvenile Probation Settings","Scaling up eConnect in Juvenile Probation Settings: a Hybrid Implementation Effectiveness Trial of a Digital Suicide Risk\u002FBehavior Identification and linkage-to Treatment System","Sample: County Probation Staff\n\nInclusion Criteria:\n\n* All probation agency leadership and officers employed by the partnering sites who are (a) at least 18 years of age and (b) conversant in English in participating study counties are eligible\n\nExclusion Criteria:\n\n* There are no exclusionary criteria and no special classes of participants.\n\nSample: County Treatment Staff\n\nInclusion Criteria:\n\n* All treatment staff (agency directors, supervisors and clinical line staff) employed by participating treatment agencies who are at least 18 years of age and conversant in English in participating study counties will be asked to participate\n\nExclusion Criteria:\n\n* There are no exclusionary criteria and no special classes of participants.\n\nSample: Local Facilitators\n\nInclusion Criteria:\n\n* All county\u002Flocal Justice Diversion Alternatives Initiative (JDAI) representatives that work with partnering sites who (a) are at least 18 years of age and (b) conversant in English in participating study counties are eligible\n\nExclusion Criteria:\n\n* There are no exclusionary criteria and no special classes of participants.\n\nSample: Probation Youth\n\nInclusion Criteria:\n\n* All youth who are on probation who are (a) 10-18 years of age and (b) conversant in English in participating study counties are eligible;\n\nExclusion Criteria:\n\n* There are no exclusionary criteria and no special classes of participants.","10 Years",{"count":79,"type":21},3629,[81],"NA","We propose to conduct research on strategies that support the successful scale-up of an evidence-based, suicidal risk and behavior identification and cross-system linkage programs for justice-involved youth (e-Connect), and to rigorously evaluate the implementation activities and associated costs that support that scale-up of e-Connect within 9 Indiana counties. Guided by the GPM and EPIS frameworks, this 4-year study will comprise 3 project phases: (1) Scale-Up Strategy Efforts, focused on preparing for scale-up; (2) e-Connect-scaleup implementation (2a Exploration and Preparation and 2b Implementation and Sustainment); and (3) Scale-Up Effectiveness Trial\u002FOutcome Evaluation. The current project draws on lessons learned from the e-Connect efficacy trial in NYS and research team leadership will serve as External Facilitators to support 9 Local Facilitators to ensure the successful transfer of knowledge, skill and expertise in delivering e-Connect in a new JJ system and geographic context, utilizing implementation strategies to support the more widespread, sustained and rigorous adoption of e-Connect. The study will include a learning community created by External Facilitators for Local Facilitators to provide support, to exchange strategies to handle implementation issues, to develop competencies in facilitation, and to guide implementation throughout the program. The learning community will help Local Facilitators navigate through the implementation stages of the study.",[84],"Suicide","2026-06-28",{"date":87,"type":39},"2026-06-30",{"date":89,"type":39},"2023-05-02",{"date":91,"type":21},"2028-08-31",{"name":45,"class":46},{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":55,"sex":16,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":4,"studyType":22,"phases":104,"briefSummary":105,"conditions":106,"keywords":113,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":47},"100638259","brief-intervention-addressing-stigma-among-parents-of-children-with-mental-health-problems-100638259","NCT07594730","Brief Intervention Addressing Stigma Among Parents of Children With Mental Health Problems","RCT of Brief Intervention Addressing Stigma Among Parents of Children With Mental Health Problems","Inclusion Criteria:\n\n* Self-identify as English Speaking\n* Live in the US\n* Ages 25-50\n* Have a child 6-18 years old with either depression, ADHD, or a substance use problem\n\nExclusion Criteria:\n\n* Do not speak English\n* Do not live in the US\n* \\\u003C25 or \\>50\n* Do not have a child between ages 6-18 with depression, ADHD, or a substance use problem","25 Years","50 Years",{"count":103,"type":21},1600,[81],"The goal of this study is to test the efficacy of brief video interventions parental internalized stigma and stigma-related outcomes (e.g., treatment intentions, caregiver burden, secrecy) among parents (ages 25-50) of children ages 6-18 with depression, ADHD, or substance use problems.\n\nTimely identification and treatment of mental health problems in youth is a public health priority. However, many youth do not receive treatment, and stigma has been identified as the primary barrier to help-seeking. Parents experience stigma related to their children having mental health problems, which has been associated with reduced help-seeking and increased parental distress. Prior experiments have found brief video-based interventions (BVIs), 1-2 minute videos similar to those viewed by youth on social media platforms, based on the principle of \"social contact\" with individuals affected by a stigmatized condition, effective in reducing mental health stigma and increasing help-seeking.\n\nIn this 4-arm RCT, the investigators will recruit parents aged 25-50 using an online crowdsourcing platform, to test the efficacy of BVIs featuring a personal parent narrative of their experience with their child's a) depression, b) ADHD, or c) substance use, or d) a control condition that provides general written psychoeducational information without social contact.",[107,108,109,110,111,112],"Depression Disorders","ADHD","Substance Abuse","Social Stigma","Help-Seeking Behavior","Caregiver Burden",[114,115,116],"social stigma","help-seeking behavior","caregiver burden","NOT_YET_RECRUITING","2026-06-26",{"date":87,"type":39},{"date":121,"type":21},"2026-07-06",{"date":123,"type":21},"2026-09-06",{"name":45,"class":46},{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":16,"minAge":132,"maxAge":133,"enrollmentInfo":134,"targetDuration":4,"studyType":22,"phases":136,"briefSummary":137,"conditions":138,"keywords":141,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":47},"100515092","sleep-interventions-and-neurocognitive-outcomes-100515092","NCT05987007","Sleep Interventions and Neurocognitive Outcomes","Sleep Interventions and Neurocognitive Outcomes in Amnestic Mild Cognitive Impairment","Inclusion Criteria:\n\n1. English speaking participants, ages 60-85 years\n2. Telephone MMSE (T-MMSE) score of 22 or greater at screening assessment; T-MMSE \\\u003C18 during post-treatment visit or 6-month follow-up will be discontinued from participation of the study.\n3. Individuals with aMCI, as determined by the Wechsler Memory Scale-Revised Logical Memory Delayed Recall (LM) and Quick Dementia Rating Scale (QDRS)\n4. Presence of subject memory complains not exclusionary. Presence of subjective memory complaints without objective signs of impairment (T-MMSE, QDRS, LM) would not be considered as the presence of late MCI or dementia, therefore are not exclusionary.\n5. Participants with regular and consistent use of sleep medications (sedatives\u002Fhypnotic use of \\>3 times per week) will be excluded. Participants who take sleep medications 3 or less times per week will be asked to discontinue medications prior to the study baseline visit. All discontinuation\u002Ftapering procedures will require PI's direct consultation with participants' prescribing or primary care physicians, which will be documented to ensure participants' safety.\n6. Presence of sleep disturbance, as determined by score of 8 or greater on the Insomnia Severity Index administered at baseline (without sleep medications).\n7. Participants must have capacity to provide informed consent.\n8. Have access to stable internet connection.\n9. A family member or other individual who is in contact with the subject and consents to serve as informant during the study; this can be a telephone informant in the case of subjects who do not have a live-in informant\n\nExclusion Criteria:\n\n1. Diagnosis of stroke or excessive risk of CVD\n2. Neurologic disease including movement disorders, MS, epilepsy, and TBI (with greater than 15 min loc)\n3. Untreated diabetes\n4. Active treatment of cancer\n5. Telephone MMSE score below 22 (Newkirk et al., 2004) and Logical Memory above 11 for subjects with 16 or more years of education, 9 for subjects with 8-15 years of education, and 6 for subjects with 0-7 years of education\n6. Presence of sleep disorders other than insomnia (moderate-severe sleep apnea, REM-behavior disorder, restless legs syndrome, circadian rhythm disorder). Mild sleep apnea will not be exclusionary.\n7. Current DSM-5 Axis I psychiatric diagnosis of schizophrenia, schizoaffective disorder, substance\u002Falcohol use disorder, or bipolar disorder\n8. Use of antidepressants with known large anticholinergic properties will be excluded. These include: amitriptyline, amoxapine, clomipramine, desipramine, doxepine, imipramine, isocarboxazide, lithium, maprotiline, mirtazapine, nortriptyline, tranylcypromine trimipramine, and phenelzine. Other medications are allowed during the study and are not exclusionary.\n9. Participants taking medications with benzodiazepines properties will be excluded. These include: diazepam, quazepam, estazolam, alprazolam, clorazepate, clorazepate, oxazepam, alprazolam, chlordiazepoxide, lorazepam, flurazepam, triazolam, temazepam, and midazolam.\n10. Participants with moderate to severe depression (Geriatric Depression Scale\\>8) will be excluded from the study and will be encouraged to seek treatment for their symptoms. Participants with moderate depression (GDS 5-8) will be encouraged to return for screening after receiving treatment and seeing improvement in their symptoms.\n11. Participants who are unable to provide an informant.","60 Years","85 Years",{"count":135,"type":21},50,[81],"This protocol focuses on the effect of sleep interventions on improving sleep and building cognitive\u002Fbrain resilience in older adults with amnestic mild cognitive impairment and sleep disturbance. Two sleep interventions, cognitive behavioral therapy for insomnia (CBTI) and acoustic slow-wave activity enhancement (SWAE), will be utilized in a pilot randomized clinical trial in which participants are randomized to different treatment groups (CBTI or SWAE). Participants will be assessed over a 6-month period in order to examine the impact of sleep treatments on neuropsychological outcomes and cognitively mediated everyday functioning.",[139,140],"Sleep Disturbance","Amnestic Mild Cognitive Impairment",[142,143,144,140,145],"Alzheimer's Disease","Slow-Wave Activity","Older Adults","Cognitive Behavioral Therapy for Insomnia","2026-06-08",{"date":148,"type":39},"2026-06-09",{"date":150,"type":21},"2026-07-01",{"date":152,"type":21},"2028-12-31",{"name":45,"class":46},{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":160,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":132,"enrollmentInfo":162,"targetDuration":4,"studyType":22,"phases":164,"briefSummary":165,"conditions":166,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":47},"100424724","relapse-prevention-and-changing-habits-in-anorexia-nervosa-100424724","NCT04810624","Relapse Prevention and Changing Habits in Anorexia Nervosa","Optimizing Relapse Prevention and Changing Habits in Anorexia Nervosa","REACH+","Inclusion Criteria:\n\n* Diagnosis of Anorexia Nervosa at hospital admission\n* Medically Stable\n* Internet capability with videoconferencing\n* Weight restored (BMI \\> 19 kg\u002Fm2) at New York State Psychiatric Institute\n\nExclusion Criteria:\n\n* Current substance use or other comorbid disorder requiring specialized treatment\n* Pregnancy\n* Imminent risk of suicide\n* Serious medical illness\n* Daily psychotropic medication other than antidepressants (medications that are known effect weight are exclusionary, i.e. stimulants, olanzapine, mirtazapine)\n* Participation in outside psychotherapy or structured treatment program (support groups will be allowed). Individuals who are discharged on medications would need to have a non-study psychiatrist.",{"count":163,"type":21},60,[81],"This study aims to optimize a treatment package for the relapse prevention treatment of AN. In the Preparation Phase, we examined accessibility and feasibility of the treatment package.\n\nIn the current Optimization Phase, we will identify which components of treatment contribute to positive outcomes after acute hospitalization. We will carefully evaluate maintenance of remission, measured by rate of weight loss and end-of-trial status.",[167],"Anorexia Nervosa","2026-05-28",{"date":170,"type":39},"2026-06-01",{"date":172,"type":39},"2021-06-21",{"date":174,"type":21},"2027-06-01",{"name":45,"class":46},{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":4,"eligibilityCriteria":182,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":132,"enrollmentInfo":183,"targetDuration":4,"studyType":22,"phases":185,"briefSummary":186,"conditions":187,"keywords":189,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":191,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":47},"100413448","computer---based-treatment-for-social-anxiety-disorder-100413448","NCT04663724","Computer - Based Treatment for Social Anxiety Disorder","Computer-Based Treatment for Social Anxiety Disorder, A Randomized Controlled Trial","Inclusion Criteria:\n\n* Males and females between the ages of 18 to 60\n* Current primary diagnosis of SAD\n* Score of at least 50 on the Liebowitz Social Anxiety Scale (self-rated version)\n* Fluent in English\n* Willing and able to give informed written consent\n* Ability to participate responsibly in the protocol\n* Normal or corrected-to-normal vision\n\nExclusion Criteria:\n\n* Present or past psychotic episode, psychotic disorder, schizophrenia, schizoaffective disorder, or bipolar disorder\n* Current severe depression\n* Suicidal ideation or behavior\n* Current diagnosis of post-traumatic stress disorder, obsessive-compulsive disorder, bipolar disorder, manic episode or tic disorder\n* Current or past organic mental disorder, seizure disorder, epilepsy or brain injury\n* Current unstable or untreated medical illness\n* Severe alcohol use disorder, severe cannabis use disorder, and any severity of other substance use disorder (except nicotine use disorders)\n* Use of psychiatric medication in the past month other than a stable dose of selective serotonin reuptake inhibitors (SSRIs) for at least 3 months\n* Any concurrent cognitive behavioral therapy or other psychotherapy that was initiated in the past 3 months\n* Pregnancy, or plans to become pregnant during the period of the study (will be assessed by urine)\n* Contraindication to MRI scanning (Paramagnetic metallic implants or devices contraindicating magnetic resonance imaging or any other non-removable paramagnetic metal in the body)\n\n  1. pacemaker\n  2. paramagnetic metallic prosthesis\n  3. surgical clips\n  4. shrapnel\n  5. necessity for constant medicinal patch\n  6. some tattoos\n* Inability to tolerate MRI scanning procedures (i.e., severe obesity, claustrophobia)",{"count":184,"type":21},80,[81],"The present study is a controlled trial that seeks to examine the feasibility, acceptability, mechanism, and efficacy of a recently developed computer-based therapy in individuals with social anxiety disorder (SAD)",[188],"Social Anxiety Disorder",[190],"Attention",{"date":170,"type":39},{"date":193,"type":39},"2021-02-15",{"date":195,"type":21},"2027-02-28",{"name":45,"class":46},{"id":198,"slug":199,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":201,"acronym":4,"eligibilityCriteria":202,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":132,"enrollmentInfo":203,"targetDuration":4,"studyType":22,"phases":205,"briefSummary":206,"conditions":207,"keywords":209,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":47},"100602535","helping-adults-with-obsessive-compulsive-disorder-succeed-at-work-100602535","NCT07124780","Helping Adults With Obsessive-Compulsive Disorder Succeed at Work","Inclusion Criteria:\n\n* Currently unemployed and interested in finding competitive employment in New York State\n* Currently residing in New York State\n* Primary diagnosis of OCD\n* For those currently on psychiatric medication: On a stable dose of psychiatric medication (for at least 6 weeks) and willing to remain on this dose for the first three months of CBT.\n* Access to the internet through a mobile device or computer\n\nExclusion Criteria:\n\n* In the process of applying for or currently receiving disability benefits\n* Currently receiving supported employment services\n* Active suicidality or recent suicide attempt\n* Active substance use problem (other than nicotine) that warrants treatment\n* Comorbid psychiatric conditions that significantly elevate the risk of study participation such as psychotic disorders or bipolar disorder",{"count":204,"type":21},40,[81],"The purpose of this study is to compare two models of employment services for people with obsessive-compulsive disorder (OCD) interested in finding and maintaining employment. All 40 participants will receive up to 12 sessions of the first-line treatment for OCD called exposure and response prevention, a form of Cognitive Behavioral Therapy (CBT). Assigned by chance, half of the people will also receive Individual Placement and Support (IPS); the other half will receive standard vocational services (SVS). This study will compare these two approaches for helping adults with OCD find and maintain work.",[208],"Obsessive-Compulsive Disorder (OCD)",[210,211],"supported employment","obsessive-compulsive disorder","2026-05-18",{"date":214,"type":39},"2026-05-19",{"date":216,"type":21},"2026-04-21",{"date":218,"type":21},"2027-08",{"name":45,"class":46},{"id":221,"slug":222,"hasResults":11,"nctId":223,"briefTitle":224,"officialTitle":224,"acronym":225,"eligibilityCriteria":226,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":227,"targetDuration":4,"studyType":22,"phases":229,"briefSummary":232,"conditions":233,"keywords":235,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":247},"100440128","phase-2-efficacy-of-buprenorphine-and-xr-naltrexone-combination-for-relapse-prevention-in-opioid-use-disorder-100440128","NCT05011266","Efficacy of Buprenorphine and XR-Naltrexone Combination for Relapse Prevention in Opioid Use Disorder","COMBO","Inclusion Criteria:\n\n* Individuals between the ages of 18-65 (inclusive) interested in antagonist-based relapse prevention treatment\n* Meets current DSM-5 criteria for current opioid use disorder of at least six months duration supported by urine toxicology positive for opioids OR positive naloxone challenge (defined by 3-point increase in COWS) if seeking detoxification and XR-NTX induction OR confirmed recent detoxification treatment for opioids.\n* In otherwise good health based on complete medical history, physical examination, vital signs measurement, ECG, and laboratory tests (hematology, blood chemistry, urinalysis) with no clinically significant abnormalities\n* Participants who completed detoxification and received XR-NTX are eligible for the study. Participants may be enrolled up to 2 weeks following an initial XR-NTX injection given in any outside research or community-based treatment setting (inpatient, outpatient residential).\n* Seeking treatment for opioid use disorder, willing to accept treatment with XR-NTX and, in the judgment of the treating physician, is a good candidate for naltrexone-based treatment.\n* Voluntarily seeking treatment for opioid use disorder.\n* Able to give written informed consent to participate in the study and showing a thorough understanding of the difference between agonist and antagonist-based treatment.\n\nExclusion Criteria:\n\n* Methadone maintenance within 2 weeks of XR-NTX induction or any use of methadone in the week prior to XR-NTX induction\n* Maintenance on buprenorphine or frequent buprenorphine use in the week prior to XR-NTX induction (must be using no more than 8 mg of buprenorphine per day for no more than 3 days per week). If consenting after initial XR-NTX injection, any use of buprenorphine since XR-NTX induction is exclusionary.\n* Serious medical, psychiatric or substance use disorder that, in the opinion of the study physician, would make a detoxification and naltrexone initiation, or maintenance treatment with XR-NTX in combination with buprenorphine, hazardous (relative contraindications) or requires a different level of care. Examples include:\n\n  1. Disabling or terminal medical illness (e.g., uncompensated heart failure, severe acute hepatitis, cirrhosis or end-stage liver disease) as assessed by medical history and\u002For review of systems.\n  2. Severe, untreated or inadequately treated mental disorder (e.g., active psychosis, uncontrolled manic-depressive illness) as assessed by history and\u002For clinical interview.\n  3. Current severe alcohol, benzodiazepine, or other depressant or sedative hypnotic use likely to require a complicated medical detoxification (routine alcohol and sedative detoxifications may be included).\n  4. Suicidal or homicidal\n* AST\u002FALT \\> 3x normal limit\n* Pregnancy, lactation, or a plan of becoming pregnant. Women need to have negative blood pregnancy test at screening and agree to practice dual contraceptives.\n* Physiological dependence on alcohol or sedative-hypnotics with impending withdrawal. Other substance use diagnoses are not exclusionary.\n* History of allergic or adverse reaction to buprenorphine, naltrexone, naloxone, clonidine, or clonazepam.\n* Painful medical condition that requires ongoing opioid analgesia or anticipated surgery necessitating opioid medications.\n* Individuals above 60 with possible early cognitive decline or other neurodegenerative conditions as evidenced by a score of less than 25 on a Mini Mental Status Exam screen.\n* Participants who had 30 or more opioid-free days prior to randomization will not be eligible.\n* Participants more than 2 weeks following an initial XR-NTX injection (given in any outside research or community-based treatment setting, for example inpatient, outpatient residential).",{"count":228,"type":21},180,[230,231],"PHASE2","PHASE3","This study will evaluate the effectiveness of a new pharmacological approach to increase efficacy of treatment with extended release naltrexone (XR-naltrexone) for individuals with opioid use disorder by combining it with buprenorphine-naloxone. This is a two arm, double-blind, placebo-controlled study to examine whether addition of buprenorphine-naloxone will improve treatment retention, reduce opioid craving, and improve mood over 24 weeks of treatment with extended release naltrexone (XR-naltrexone) administered every four weeks for a total of 6 injections.",[234],"Opioid-use Disorder",[236,237,238,239],"opioid use disorder","treatment","buprenorphine","extended release naltrexone","2026-05-15",{"date":214,"type":39},{"date":243,"type":39},"2023-04-18",{"date":245,"type":21},"2027-01-01",{"name":45,"class":46},2,{"id":249,"slug":250,"hasResults":11,"nctId":251,"briefTitle":252,"officialTitle":252,"acronym":253,"eligibilityCriteria":254,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":255,"targetDuration":4,"studyType":22,"phases":257,"briefSummary":258,"conditions":259,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":267,"locationsCount":268},"100455257","phase-4-clozapine-for-the-prevention-of-violence-in-schizophrenia-a-randomized-clinical-trial-100455257","NCT05208190","Clozapine for the Prevention of Violence in Schizophrenia: a Randomized Clinical Trial","REVISIT-C","Inclusion Criteria:\n\n* Diagnostic and Statistical Manual-5 (DSM-5) diagnosis of schizophrenia or schizoaffective disorder by the Structured Clinical Interview for DSM-5 (SCID-5)\n* commission of a minor or serious act of violence as measured by the MCVI in the last six months\n* willing and able to provide informed consent\n* medically stable in judgment of physician providing study treatment\n* appropriate for treatment with either clozapine or TAU, i.e., that there is clinical equipoise between the two treatment options. Individuals who are currently medication free or on any antipsychotic, with the exception of clozapine or long-acting injectable medication with a dosing interval of more than 30 days will be eligible\n\nExclusion Criteria:\n\n* An unstable of serious medical or neurological condition including a myeloproliferative disorder or condition that surprises the bone marrow\n* A history of intolerance\u002Fallergy to clozapine (e.g., agranulocytosis, small bowel obstruction, or myocarditis)\n* A history of intellectual impairment\n* pregnant or lactating women; women who are able to become pregnant but who are not willing to sue effective methods of birth control\n* Individuals who score a 3, 4, or 5 within the previous month on the suicidal ideation section of the Columbia Suicide Severity Rating Scale (CSSRS), have any suicidal behavior (not including Not Suicidal Self Injury) within the previous 3 months, or are, in the opinion of the investigator, at too high of a risk for suicide to be safety treated in a randomized trial in which they may not be treated with clozapine\n* Documented intolerance to or lack of any therapeutic benefit with clozapine after a full trial",{"count":256,"type":21},280,[24],"Two-hundred and eighty individuals with schizophrenia who have a recent history of violent acts will be randomized in this 2-arm, parallel-group, 24-week, open-label, 7-site clinical trial to examine the effects of treatment with clozapine vs antipsychotic treatment as usual (TAU) for reducing the risk of violent acts in real-world settings",[260,28],"Schizophrenia","2026-04-28",{"date":263,"type":39},"2026-05-04",{"date":265,"type":39},"2022-03-17",{"date":152,"type":21},{"name":45,"class":46},7,{"id":270,"slug":271,"hasResults":11,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":275,"eligibilityCriteria":276,"healthyVolunteers":55,"sex":16,"minAge":77,"maxAge":277,"enrollmentInfo":278,"targetDuration":4,"studyType":22,"phases":280,"briefSummary":281,"conditions":282,"keywords":4,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":284,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":4},"100561692","mindfulness-based-substance-use-prevention-minds-up-100561692","NCT06593470","Mindfulness-Based Substance Use Prevention (MINDS-UP)","Mindfulness-Based Substance Use Prevention (MINDS-UP): a Randomized Controlled Trial","MINDS-UP","Inclusion Criteria:\n\n* Youth is ages 10-14 years on the day of screening \\[i.e., does not turn 15 before or on the day of screening\\]\n* Access to a smart phone, tablet, or computer with Wi-Fi\n* English-speaking\n\nExclusion Criteria:\n\n* Has been diagnosed with or received treatment for one of the following mental health problems: depression, bipolar disorder, schizophrenia, autism spectrum disorder, intellectual disability, or substance use disorder.\n* Youth is actively involved in another Boricua Youth Study (BYS)\n* Youth's sibling is or has previously been enrolled in MINDS-UP.","14 Years",{"count":279,"type":21},45,[81],"The goal of this clinical trial is to test the feasibility, behavioral\u002Fneural mechanisms, and preliminary efficacy of \"MINDfulness-based Substance Use Prevention Program,\" or \"MINDS-UP\", a novel substance use prevention meditation intervention for children and adolescents between the ages of 10 and 14. The main questions it aims to answer are:\n\n1. Is MINDS-UP feasible and what is its preliminary efficacy?\n2. Are MRI protocol and procedures feasible?\n\nAn additional exploratory question is:\n\nAre there neural and psychopathological mechanisms through which MINDS-UP might work?\n\nResearchers will compare Sport - Prevention Plus Wellness (PPW) (an evidence based substance use prevention program) to Sport - Prevention Plus Wellness + MINDS-UP to examine the preliminary efficacy of MINDS-UP.\n\nParticipants will\n\n* take assessment #1\n* have 2 MRIs and take MINDS-UP, just take MINDS-UP or have a delayed start\n* take assessment #2\n* take PPW, a single remote and research assistant-delivered 45-minute session\n* take assessment #3\n* take assessment #4",[283],"Substance Use",{"date":285,"type":39},"2026-04-24",{"date":287,"type":21},"2026-10-01",{"date":289,"type":21},"2028-01-01",{"name":45,"class":46},{"id":292,"slug":293,"hasResults":11,"nctId":294,"briefTitle":295,"officialTitle":296,"acronym":4,"eligibilityCriteria":297,"healthyVolunteers":11,"sex":16,"minAge":298,"maxAge":299,"enrollmentInfo":300,"targetDuration":4,"studyType":22,"phases":302,"briefSummary":303,"conditions":304,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":247},"100475974","impacts-of-cash-transfers-on-child-neurodevelopment-auxilio-brasil-100475974","NCT05477901","Impacts of Cash Transfers on Child Neurodevelopment (Auxilio Brasil)","Mental Health and Bolsa Familia: A Mechanistically Focused Clinical Trial of a Cash Transfer Intervention on Child Brain, Behavior, and Mental Health","Mother:\n\nInclusion Criteria:\n\n1. Age 23-45 years old\n2. Receiving AB cash transfers\n3. Has at least two or more children ages 7- 10 years old at time of recruitment (up to 4 children per family)\n4. Able to consent\n\nExclusion Criteria:\n\n1\\. Mother and child do not reside in same household\n\nChild:\n\nInclusion Criterion\n\n1. Age 7-10 years old\n2. Intellectual Disability\n\nExclusion Criterion\n\n1. Does not reside in same household as the mother\n2. Major Axis I disorder (e.g., Autism, Schizophrenia, Bipolar)\n3. Severe Disability\n4. MRI contradictions (index child only)","23 Years","45 Years",{"count":301,"type":21},450,[81],"This study examines the impact of Auxilio Brasil (AB), a cash transfer program to mothers of school-age children, on resource-deprived populations in Brazil and its protective effects on child neurodevelopment and mental health. The investigators will conduct a randomized clinical trial (RCT) among those already receiving AB in which 300 families will be randomized in a 1:1 ratio to receive either a high ($40\u002Fmonth) or low ($2\u002Fmonth) supplemental transfer for 2 years. Three hundred children (index child participants; 7-10 years old) will be enrolled across both study arms. Additionally, up to 150 siblings (\"sibling participants;\" 7-10 years old) will be enrolled. Eligible families who decide to participate will sign a study-specific informed consent (mother) and assent (child) form. The UNIFESP team will conduct the respective assessments at baseline, approximately 8- and 16- months, 24-months and approximately 6-months post-RCT.\n\nAim 1: Determine the impact of high vs low cash transfers on children's exposure to adversities (ACEs) and neurodevelopment.\n\nAim 2: Determine the impact of cash transfers on children's inflammatory markers and HPA activity\u002Fcortisol.\n\nExploratory Aim: The investigators will explore (i) whether sex\u002Fgender of the children moderates the pathways in the above mediation model; and (ii) whether cash transfer-related effects persist 6 months post-RCT.",[305,306,307,308],"Inflammation","HPA","CBCL","Family Relations","2026-04-20",{"date":311,"type":39},"2026-04-23",{"date":313,"type":39},"2025-05-28",{"date":315,"type":21},"2029-01-31",{"name":45,"class":46},{"id":318,"slug":319,"hasResults":11,"nctId":320,"briefTitle":321,"officialTitle":322,"acronym":4,"eligibilityCriteria":323,"healthyVolunteers":55,"sex":16,"minAge":17,"maxAge":324,"enrollmentInfo":325,"targetDuration":4,"studyType":22,"phases":326,"briefSummary":327,"conditions":328,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":329,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":334,"locationsCount":247},"100397701","phase-1-clinical-trials-of-multivalent-opioid-vaccine-components-100397701","NCT04458545","Clinical Trials of Multivalent Opioid Vaccine Components","Phase 1A\u002F1B Clinical Trials of Multivalent Opioid Vaccine Components","1. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.\n2. Males and females aged 18 to 59 years.\n3. Females must be non-pregnant, non-lactating and either be of non-childbearing potential (i.e. sterilized via hysterectomy or bilateral tubal ligation or at least 1 year post-menopausal) or of childbearing potential but practicing a medically acceptable method of birth control\n4. Meets current DSM 5 criteria for moderate-severe Psychiatric OUD, physical dependence on opioids, and current use of Examination opioids will be in amounts and\u002For frequencies that meet or exceed those used in the study (3-4 tablets of a prescription opioid medication per day or 1-2 bags of heroin and\u002For fentanyl per day). Participants may meet criteria for other behavioral disorders (e.g. gambling) or substance use disorders (cocaine or marijuana), but cannot be physically dependent on drugs that pose risk of withdrawal that requires medical management such as alcohol or benzodiazepines. Participant must self-identify their opioid of choice as being other than oxycodone, oxymorphone, hydrocodone, and hydromorphone (e.g., a heroin and\u002For fentanyl user). In addition, we will only include individuals who have prior experience with intranasal opioid use. Only participants with a minimum use of 1-2 bags of heroin and\u002For fentanyl per day and a maximum of 20 bags of heroin\u002Ffentanyl per day will be enrolled. The lower limit ensures that participants are physically dependent on opioids and are able to tolerate the proposed morphine maintenance regimen. The upper limit is consistent with our current experience in recruiting this population (where use of 30-50 bags\u002Fday is commonly reported because of the shorter duration of psychoactive effects produced by fentanyl compared to heroin).\n5. Not currently seeking treatment for drug use as defined by urine samples positive for illicit opioids, and at least 2 urine samples negative for buprenorphine and methadone, spaced at least 3 days apart, prior to enrollment.\n6. Willing and able to comply with scheduled visits, dosing plan, laboratory tests, and other study procedures.\n7. Patients who weigh less than 300 pounds and \u002For have less than a maximum girth of 52 inches.\n\nExclusion Criteria\n\n1. Participation in a clinical trial and receipt of investigational drug(s) during 30 days (or 5 half-lives, whichever is longer) prior to randomization.\n2. Sensitivity, allergy, or contraindication to opioids, alum, or any components of the vaccine\n3. Prior exposure to opioid vaccines or vaccines containing Keyhole Limpet Hemocyanin.\n4. Use of prescription psychotropic medications that would potentially interfere with study procedures\n5. Women of childbearing age who are pregnant, lactating or, not practicing or willing to begin a medically acceptable method of birth control.\n6. Cannot read or understand the self-report assessment forms unaided or are so severely disabled that they cannot comply with the requirements of the study.\n7. Medical conditions that may make study participation hazardous:\n\n   * History of seizures or cardiac risk conditions (unstable angina, cardiac arrhythmias, chest pain, strong palpitations (subjectively defined as the feeling that the heart is beating too hard, too fast, skipping a beat, or fluttering).\n   * Elevated liver function tests (i.e., AST and ALT \\> 2 times the upper limit of normal).\n   * Impaired renal function (creatinine \\> 1.2).\n   * Hypertension (\\>140\u002F90).\n   * Asthmatic symptoms within the past 3 years.\n   * Active hepatitis \\[e.g. symptomatic with a positive test for hepatitis B (HBsAg), hepatitis C antibody (HCV), HIV1\u002FHIV2 antibody\u002Fantigen\\].\n   * Significant hepatocellular injury as evidenced by elevated bilirubin levels (\\>1.3), or elevated levels (over 3x the upper limit of normal) of aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT).\n   * Creatinine clearance estimated to be less than 60 ml\u002Fmin.\n   * Current gastric disease such as peptic ulcer disease, gastritis, upper gastrointestinal bleeding, or any gastrointestinal malignancy or precancerous condition.\n   * Sleep apnea as assessed by the STOP-Bang questionnaire; those with high risk will be excluded from the study\n   * Hemoglobin: Women \\\u003C11.5; men \\\u003C13.\n8. Newly diagnosed HIV infection or known HIV infection with CD4 counts below normal levels, active tuberculosis, or other immunocompromising diseases.\n\n   For HIV testing, we follow guidelines from the New York State Department of Health (https:\u002F\u002Fwww.health.ny.gov\u002Fdiseases\u002Faids\u002Fproviders\u002Ftesting\u002Fdocs\u002Ftesting\\_fact\\_sheet.pdf)\n9. Current chronic pain (persistent for longer than 3 months).\n10. Current or history of psychotic disorder or other severe Axis I disorder based on DSM 5 criteria, other than OUD, including physical dependence on drugs that pose risk of withdrawal that requires medical management such as alcohol or benzodiazepines. Participants diagnosed with dysthymia or mild-moderate depression with no recent suicidal ideation may be included. Recent suicidal ideation\" is defined as thoughts about suicide within the past month.\n11. Previous serious or unexpected adverse reaction to a vaccine, including GuillainBarré syndrome.\n12. Use of inhaled corticosteroids, immunosuppressive agents or other medications within 30 days prior to administration of investigational product that might interfere with an immune response. Antihistamines may not be used within 7 days prior to administration of investigational product.\n13. Use of any vaccine, with the exception of influenza vaccine, or COVID-19 vaccine 30 days prior to administration of study product. Participants who have received the Moderna or Pfizer COVID-19 vaccine will not be eligible to receive study product until 30 days after they have received the second vaccine dose; participants who have received the Johnson and Johnson COVID-19 vaccine will not be eligible to receive study product until 30 days after they have received the vaccine dose.\n14. Known history of cancer or cancer treatment within 12 months prior to administration of investigational product.\n15. Receipt of blood products within 3 months of screening.\n16. Anticipated inability to fulfill all visits and examination procedures throughout the study period (approximately 12 months).\n17. Individuals who are on medication-assisted treatment for Opioid Use Disorder (e.g., buprenorphine, buprenorphine\u002Fnaloxone, methadone, naltrexone). We will also exclude participants from our study who \"doctor shop\" by reviewing information obtained from PMPs.\n18. Individuals who currently (within the past 3 months) have a temporary restraining order (TRO) against them or against another person.","59 Years",{"count":279,"type":21},[60,230],"Currently, abuse of prescription opioid analgesics and heroin is a serious problem in the U.S. Although several medications, including methadone, buprenorphine, and naltrexone, are available and effective in treating opioid use disorder (OUD), long-term relapse rates remain high. The current study is designed to examine a new approach to treating OUD, namely use of a vaccine targeted against oxycodone \\[Oxy(Gly)4-sKLH\\], one of the most commonly abused prescription opioids. The vaccination approach to treating substance use disorders relies on the ability of the vaccine to produce antibodies that bind the target drug in blood and reduce its ability to enter the brain. The long-term goal of this research will be to develop a combined vaccine against oxycodone and heroin. However, in this trial the Oxy(Gly)4-sKLH vaccine will be studied separately. This is a multi-site study, being conducted at the New York State Psychiatric Institute and the Clinilabs clinical research unit (CRU) in Eatontown, New Jersey. The current study proposes to evaluate safety (Aim 1), degree of antibody production (Aim 2), and efficacy (i.e., ability to reduced drug liking following opioid administration) (Aim 3). The oxycodone vaccine (Oxy(Gly)4-sKLH) will be tested in participants with OUD (target # completers = 45 across two study sites). This study will provide a great deal of information about the safety and potential effectiveness of the Oxy(Gly)4-sKLH vaccine in reducing the abuse of opioids.\n\nThe NYSPI site is currently paused and has been paused since an institutional pause on human subjects research began in June 2023. The U.S. Department of Health and Human Services (HHS) Office of Human Research Protections (OHRP) issued an FWA restriction on NYSPI research that also included a pause of human subjects research as of June 23, 2023.",[234],{"date":311,"type":39},{"date":331,"type":39},"2020-10-08",{"date":333,"type":21},"2027-03-30",{"name":45,"class":46},{"id":336,"slug":337,"hasResults":11,"nctId":338,"briefTitle":339,"officialTitle":340,"acronym":4,"eligibilityCriteria":341,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":101,"enrollmentInfo":342,"targetDuration":4,"studyType":22,"phases":344,"briefSummary":345,"conditions":346,"keywords":349,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":354,"startDateStruct":356,"completionDateStruct":357,"leadSponsor":359,"locationsCount":47},"100625508","phase-1-a-petmri-study-of-cobenfy-on-dopamine-transmission-in-schizophrenia-100625508","NCT07423546","A PET\u002FMRI Study of Cobenfy on Dopamine Transmission in Schizophrenia","A Multimodal PET\u002FMRI Study of Cobenfy on Dopamine Transmission in Schizophrenia","Inclusion Criteria:\n\n1. Individuals aged 18 to 50, inclusive at screen\n2. Capable of understanding the study procedures and able to provide informed consent\n3. Diagnosed with schizophrenia, schizoaffective, or schizophreniform disorder\n4. Antipsychotic free at Visit 1 (by choice and for reasons unrelated to the study), and for at least 3 weeks (4 for aripiprazole, Cobenfy or LAIs) at the time of the baseline PET scan, inclusive of any antipsychotic-free time prior to consent\n5. PANSS total score \\> 80 and \\\u003C 120\n6. Willing to use qualified methods of contraception (listed in section 5.3) for the study duration (for women of childbearing potential only)\n7. Stable dosing of herbal\u002Fdietary supplements for at least 6 weeks at the time of the first dose of Cobenfy and willingness to avoid products with known hepatotoxic ingredients (e.g., green tea extract, kratom, ashwagandha).\n\nExclusion Criteria:\n\n1. Diagnosis of moderate or severe substance use disorder within the previous month (from first PET scan)\n2. A history of poor or inadequate response to Cobenfy for any reason, hypersensitivity to Cobenfy or trospium or no justifiable reason to expect improvement on Cobenfy, or treatment with Cobenfy within 4 weeks of the first PET Scan\n3. EKG abnormality that is clinically significant including a QT interval \\> 450 msec for men and \\> 470 msec for women, as corrected by the Fridericia formula (QTcF)\n4. Pregnant or breast-feeding women. Women of child-bearing potential must have a negative serum β-hCG pregnancy test at Visit 1, must have been using an acceptable method of contraception (section 5.3) for 30 days before the study, and must agree to do so for the whole study and 30 days after (unless post-menopausal or surgically sterile)\n5. Any clinically significant or unstable medical illness, condition, or disorder that is anticipated to potentially compromise participant safety on study medication, including (but not necessarily limited to) the following: urinary retention, moderate or severe hepatic impairment, gastric retention, untreated narrow-angle glaucoma, hypernasality, resting heart rate \\>100 bpm or systolic Blood Pressure \\>150 mmHg, a history of orthostatic hypotension or abnormal orthostatic blood pressure (change in mean arterial pressure \\[1\u002F3 systolic + 2\u002F3 diastolic\\] of \\> 20% between supine and standing blood pressures), known human immunodeficiency virus (i.e., by history), cirrhosis, biliary duct abnormalities, hepatobiliary carcinoma, symptomatic gallstone disease, active hepatic infections, history of bladder stones, recurrent urinary tract infections, or International Prostate Symptom Score \\> 7 or any one item \\> 2 (not including the nocturia item).\n6. Any material in the body that is a contraindication for MRI procedures or participated in prior nuclear medicine procedures in the past year that exceed FDA-defined limits when combined with radiation dosimetry from PET scanning in this protocol to avoid exceeding annual dosimetry limits (metal screener repeated before MRI scan during visit 2)\n7. Participants with suicidal ideation with intent or plan (indicated by affirmative answers to items 4 or 5 of the Suicidal Ideation section of the baseline C-SSRS) in the past 1 month or suicidal behavior in the past 3 months\n8. Laboratory abnormality that would compromise the well-being of the participant, including Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) value \\> 2 times the upper limit of the laboratory normal reference range, elevated bilirubin (i.e., \\>2 x upper limit of normal (ULN)), or serum prostate specific antigen (PSA) \\>10 ng\u002Fml (for men only).\n9. A history of treatment resistance to antipsychotics\n10. Use of nicotine products within the previous month (prior to first PET scan)\n11. History of significant violent behavior when antipsychotic-free or currently homicidal\n12. Positive toxicology screen for any substances of abuse",{"count":343,"type":21},12,[60,230],"This is a single site clinical trial in which 12 participants with schizophrenia will be randomized to one of three doses of treatment with Cobenfy for 5 weeks. \\[18F\\]DOPA PET scans will be obtained before and after treatment to examine the effects of Cobenfy on dopamine transmission.\n\nThe overall objective of the current study is to measure Cobenfy's ability to engage its putative target (DA transmission\u002Fsynthesis capacity in the striatum and midbrain as measured by \\[18F\\]DOPA Kicer (\\[18F\\]DOPA relative uptake rate)).",[347,348],"SCHIZOPHRENIA 1 (Disorder)","Schizoaffecitve Disorder",[350,351,352],"Cobenfy","PET","MRI","2026-04-06",{"date":355,"type":39},"2026-04-13",{"date":150,"type":21},{"date":358,"type":21},"2027-12-31",{"name":45,"class":46},{"id":361,"slug":362,"hasResults":11,"nctId":363,"briefTitle":364,"officialTitle":364,"acronym":365,"eligibilityCriteria":366,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":367,"enrollmentInfo":368,"targetDuration":4,"studyType":22,"phases":370,"briefSummary":371,"conditions":372,"keywords":374,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":376,"startDateStruct":378,"completionDateStruct":379,"leadSponsor":381,"locationsCount":4},"100591198","phase-1-a-multimodal-imaging-study-of-dopamine-in-early-psychosis-100591198","NCT06977308","A Multimodal Imaging Study of Dopamine in Early Psychosis","MISDEP","Inclusion Criteria:\n\n1. Males or females between 18 and 30 years old\n2. Capacity to give informed consent\n3. Clinical High Risk (i.e., APSS, GRDS, BIPS)\n4. Antipsychotic free for 3 weeks before the PET scan\n5. Clinically stable enough for the study\n\nExclusion Criteria:\n\n1. Any substance use disorder, of any severity, within the previous month (before PET scan; not including nicotine or caffeine)\n2. Any current use of substance of abuse besides THC\u002Fmarijuana\u002Fcannabis\u002Fnicotine\u002Fcaffeine (on day of PET only)\n3. Daily tobacco use\n4. Pregnancy\n5. Lactation\n6. Presence of insulin-dependent diabetes\n7. IQ \\\u003C 70 (i.e., WTAR \\\u003C 6)\n8. Acute risk for suicide (i.e., score of 4-5 within the previous month or 6 within the previous 3 months on the CSSRS) or violence, or history of severe violent behavior that may be exacerbated by methylphenidate\n9. Presence of metallic objects in the body\n10. Lifetime exposure to radiation in the workplace (i.e., being badged for radiation exposure), or exposure to radiation in the context of research protocol within the previous year that exceeds annual limits\n11. More than one risk factor for coronary artery disease (e.g., smoking, hyperlipidemia, sedentary lifestyle)\n12. Hypertension\n13. Presence of clinically significant brain abnormalities. \\[For PET Scan Only\\]\n14. Previous adverse reaction to stimulants that would preclude receiving methylphenidate\n15. Presence or positive history of any cardiovascular disease, medical or neurological condition that would preclude methylphenidate administration or participation in this study\n16. A history of bipolar disorder Type 1, or any history of syndromal psychosis\n17. Lack of effective birth control","30 Years",{"count":369,"type":21},115,[60],"The development of new treatments for psychosis, a psychiatric condition that is prevalent and highly disabling despite antipsychotic medications, has been limited, in part, by a lack of information from brain imaging studies during the period that leads to the development of psychotic symptoms. In this project the investigators will use Positron Emission Tomography (PET) and neuromelanin-sensitive magnetic resonance imaging (NM-MRI) to examine a brain chemical that is involved in schizophrenia called dopamine and where it first becomes abnormal. The investigators will use multimodal PET\u002FMR imaging (i.e., \\[11C\\]raclopride w\u002FMPH challenge and NM-MRI) in the same CHR patients. The investigators will recruit 115 clinical high risk individuals. All subjects will undergo \\[11C\\]raclopride w\u002Fmethylphenidate challenge and neuromelanin-MRI imaging along with clinical assessments. Patients will be followed every 3 months for two years or until conversion to psychosis, whichever comes first, to assess for conversion to psychosis and clinical outcomes.",[373],"Clinical High Risk for Psychosis (CHR)",[375],"clinical high risk for psychosis",{"date":377,"type":39},"2026-04-08",{"date":170,"type":21},{"date":380,"type":21},"2030-10-01",{"name":45,"class":46},{"id":383,"slug":384,"hasResults":11,"nctId":385,"briefTitle":386,"officialTitle":387,"acronym":4,"eligibilityCriteria":388,"healthyVolunteers":11,"sex":16,"minAge":389,"maxAge":18,"enrollmentInfo":390,"targetDuration":4,"studyType":22,"phases":391,"briefSummary":392,"conditions":393,"keywords":399,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":407,"startDateStruct":409,"completionDateStruct":411,"leadSponsor":413,"locationsCount":47},"100514108","rtms-and-cognitive-behavioral-therapy-for-cocaine-use-disorder-100514108","NCT05974202","rTMS and Cognitive-behavioral Therapy for Cocaine Use Disorder","Augmenting Cognitive-behavioral Therapy With rTMS of the Medial Prefrontal and Anterior Cingulate Cortices for the Treatment of Cocaine Use Disorder","Inclusion Criteria:\n\n1. Age 22-65;\n2. Able to give informed consent and comply with study procedures;\n3. Meets DSM-5 criteria for current moderate\u002Fsevere CUD and are treatment-seeking;\n4. Used cocaine at least 9 days in the past 28 days, with at least weekly cocaine use;\n5. Agree to no more than moderate alcohol consumption (\\\u003C15 drinks\u002Fweek for men and \\\u003C8 drinks\u002Fweek for women) and to avoid using amphetamine\u002Fmethamphetamine and non-prescribed benzodiazepines or barbiturates; and\n6. Women of childbearing potential must agree to use a method of contraception with proven efficacy and agree to not become pregnant during the study.\n\nExclusion Criteria:\n\n1. Meets DSM-5 criteria for current moderate\u002Fsevere major depressive episode, OCD, bipolar disorder, schizophrenia or any psychotic disorder other than transient psychosis due to substance use;\n2. Hamilton Depression Rating Scale score \\> 17;\n3. Young Mania Rating Scale score \\>10;\n4. Meets DSM-5 criteria for current moderate\u002Fsevere other substance use disorder (aside from tobacco use disorder; physiologic dependence on any other substance other than nicotine, including alcohol, is exclusionary);\n5. Heavy weekly alcohol drinking as defined by an average of \\>14 drinks\u002Fweek for men or \\>7 drinks\u002Fweek for women on average during the past 28 days;\n6. Prior alcohol, benzodiazepine, or barbiturate withdrawal that resulted in hospitalization, medical detoxification, or resulted in seizures or delirium tremens;\n7. More than twice weekly use of non-prescribed medications\u002Fdrugs that may change the seizure threshold, including benzodiazepines, barbiturates, GHB\u002FGBL, amphetamines\u002Fmethamphetamine;\n8. Any other current DSM-5 psychiatric disorder(s) that in the investigator's judgment are unstable, would be disrupted by study procedures, or are likely to require pharmacotherapy or psychotherapy during the study period;\n9. Significant current suicide risk, indicated by either: (1) \"yes\" response on #3, 4, or #5 on the C-SSRS and a psychiatric risk assessment indicating a moderate or high risk of suicide or (2) suicidal behavior in the past 3 months (note: non-suicidal self-injurious behavior is not exclusionary);\n10. Females with a positive urine pregnancy test;\n11. Clinically significant abnormal cardiac functioning per electrocardiogram (ECG) (required for any participant age 60 years and older);\n12. Seizure history including: seizure disorder\u002Fepilepsy, alcohol\u002Fdrug withdrawal seizure, or seizure deemed by the study physician to be related to cocaine intoxication\u002Fwithdrawal (note: febrile seizures are not exclusionary)\n13. Other medical conditions that are relatively contraindicated with TMS (seizure disorders, glaucoma, increased intracranial pressure, severe migraines, stroke, brain lesions, pregnancy or breast-feeding, neurodegenerative disease, meningoencephalitis, intracerebral abscess, parenchymal or leptomeningeal cancers);\n14. Medications that lower seizure threshold and in the opinion of the investigator impose significant seizure risk for the individual (including bupropion, antipsychotics, lithium, anticholinergics, and tricyclic antidepressants);\n15. Cognitive disorder (MMSE \\\u003C25);\n16. Disqualifying response on the TMS Adult Safety Screen (TASS);\n17. Implanted devices or stimulators (cardiac pacemakers, vagus nerve stimulators, spinal cord stimulators, cochlear implant);\n18. Currently taking ototoxic medications (aminoglycosides, cisplatin);\n19. Metal implants or paramagnetic objects in the body that prohibits MR scanning;\n20. Claustrophobia that prohibits MR scanning; or\n21. Legally mandated (e.g., to avoid incarceration or other penalties) to participate in SUD treatment program.","22 Years",{"count":20,"type":21},[81],"The goal of this clinical trial is to compare the effects of active repetitive transcranial magnetic stimulation (rTMS) to sham (placebo) rTMS prior to cognitive-behavioral therapy (CBT) as a treatment for adults with cocaine use disorder. The main questions it aims to answer are:\n\n* Is rTMS safe and feasible as an augmentation for CBT for the treatment of cocaine use disorder?\n* What is the brain mechanism of rTMS?\n* Will active rTMS (compared to sham rTMS) followed by CBT help adults with cocaine use disorder achieve abstinence from cocaine?\n\nParticipants will:\n\n* Have two brain MRI scans;\n* Undergo 3 weeks of daily rTMS (or sham) treatments (15 sessions), and;\n* Have 12 weeks of once-weekly cognitive-behavioral therapy for the treatment of cocaine use disorder.\n\nResearchers will compare active (real) rTMS to sham (placebo) rTMS. All participants will receive cognitive-behavioral therapy.\n\nThe former principle investigator, Dr. Derek Blevins, has vacated his position (February 2025), and has transferred the principle investigator role to Dr. John Mariani, the STARS Clinic Director.",[394,395,396,397,398],"Cocaine Use","Cocaine Dependence","Cocaine Use Disorder","Cocaine Use Disorder, Moderate","Cocaine Use Disorder, Severe",[400,401,402,403,404,405,406],"Repetitive transcranial magnetic stimulation","rTMS","TMS","Cognitive behavioral therapy","CBT","Functional magnetic resonance imaging","fMRI",{"date":408,"type":39},"2026-04-07",{"date":410,"type":21},"2026-05-01",{"date":412,"type":21},"2028-04-28",{"name":45,"class":46},{"id":415,"slug":416,"hasResults":11,"nctId":417,"briefTitle":418,"officialTitle":419,"acronym":4,"eligibilityCriteria":420,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":421,"targetDuration":4,"studyType":22,"phases":422,"briefSummary":423,"conditions":424,"keywords":4,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":426,"startDateStruct":427,"completionDateStruct":428,"leadSponsor":430,"locationsCount":4},"100465325","phase-2-sublingual-buprenorphine-through-telemedicine-vs-in-person-care-as-usual-100465325","NCT05339256","Sublingual Buprenorphine Through Telemedicine vs In-Person Care as Usual","A Randomized, Controlled Trial of Sublingual Buprenorphine Through Telemedicine vs In-Person Care as Usual in the Treatment of Opioid Use Disorder","Inclusion Criteria:\n\n* meet DSM-5 criteria for OUD\n* Voluntarily seeking buprenorphine treatment for OUD\n* Able to provide informed consent and comply with study procedures\n\nExclusion Criteria:\n\n* Meeting DSM-5 criteria for substance use disorder other than opioid as the primary diagnosis that would compromise safety of participation in the trial as determined by the study physician, such as an alcohol or sedative hypnotic use disorder that requires detoxification\n* Having a comorbid psychiatric diagnosis that might interfere with participation or make participation hazardous, such as a psychotic disorder including schizophrenia or schizoaffective disorder\n* Concurrent methadone, buprenorphine, or vivitrol maintenance treatment\n* Known history of allergy, intolerance, or hypersensitivity to candidate medication (buprenorphine)\n* Pregnancy, lactation, or failure to use adequate contraceptive methods in female patients\n* Unstable medical conditions, such as severe hepatic, renal, or cardiovascular disease, which might make participation\n* Current or recent history history of significant violent or suicidal behavior or risk for suicide or homicide\n* Legally mandated to substance use disorder treatment.",{"count":135,"type":21},[230],"This study will compare in-person induction and maintenance dosing of sublingual buprenorphine to induction and maintenance dosing of sublingual buprenorphine through comprehensive telehealth sessions and telehealth medication for opioid use disorder (MOUD).",[425],"Opioid Use Disorder",{"date":355,"type":39},{"date":170,"type":21},{"date":429,"type":21},"2026-12-31",{"name":45,"class":46},{"id":432,"slug":433,"hasResults":11,"nctId":434,"briefTitle":435,"officialTitle":436,"acronym":4,"eligibilityCriteria":437,"healthyVolunteers":11,"sex":16,"minAge":438,"maxAge":439,"enrollmentInfo":440,"targetDuration":4,"studyType":22,"phases":441,"briefSummary":442,"conditions":443,"keywords":445,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":455,"startDateStruct":457,"completionDateStruct":459,"leadSponsor":460,"locationsCount":247},"100516032","phase-2-pimavanserin-for-rigid-compulsive-symptoms-in-autism-spectrum-disorder-100516032","NCT05999240","Pimavanserin for Rigid-compulsive Symptoms in Autism Spectrum Disorder","A Target Engagement Study of Pimavanserin for Behavioral Inflexibility With Open Label Trial for Rigid Rigid-compulsive Behavior in Adolescents and Adults With Autism","Inclusion Criteria:\n\n* Participant must be at least 12 years old and no greater than 40 years old.\n* Participants 18 years of age or older or a legally acceptable representative must be able and willing to sign an informed consent document indicating understanding of the protocol and procedures and willingness to participate in full. For a participant who is under 18 years of age, a parent or guardian must sign an informed consent document indicating understanding the protocol and procedures and willingness to participate in full. When appropriate to the participants developmental level and age, assent will be used to indicate understanding and willingness to participant. If the participant is unable to sign the assent form, the participant must provide verbal or non-verbal confirmation of willingness to continue with study procedures. Each site will abide by their respective institutional requirements regarding consent of adult informants. For adult participants at the New York site only, a parent, caregiver, or other adult informant must sign an informed consent document indicating understanding the requirements for completing their portion of the study and their willingness to participate, due to institutional human subjects requirements.\n* Participant must have a diagnosis of Autism Spectrum Disorder, according to DSM-5 criteria, made by a licensed study psychiatrist or psychologist and supported by the Autism Diagnostic Observation Schedule 2 (ADOS-2) completed at screening or within the past 12 months prior to screening by an appropriately trained professional.\n* Participant must have a Clinical Global Impression of Severity for Repetitive Behavior of 4 or greater, as rated by the study psychiatrist or psychologist at Screening and at Baseline\n* Participant must have a non-verbal IQ of greater than or equal to 70 as determined by the 4-subtest Wechsler Abbreviated Scale of Intelligence.\n* Participant must be able to speak and understand English in order to complete study measures.\n* Participant must live with a parent, primary caregiver, or other adult informant who can complete study measures on the basis of spending an average of at least 4 hours per day with the participant\n* Parent, primary caregiver, or other adult informant must speak and understand English in order to complete study measures.\n* Participant must be able to self-administer study medication or have parent\u002Fcaregiver be able to administer study medication.\n* Participant must be able to swallow study medication whole with liquid.\n* Participant or legally acceptable representative must be willing to continue current medication(s) and behavioral intervention(s) and to not add or change medication(s) or behavioral intervention(s) over the full course of the study.\n\nExclusion Criteria:\n\n* Participant is judged by the Investigator to be unable to perform or comply with all study specific requirements.\n* Participant is an employee of an investigator with direct involvement in the proposed study or other studies under the direction of a study investigator, or is a family member of an investigator.\n* Participant has a history of any severe or unstable psychiatric condition (e.g., schizophrenia or other psychotic disorder, bipolar disorder, major depressive disorder) that, in the opinion of the Investigator, could confound the interpretation of the study results or put the participant at undue risk. An acute episode of a mood disorder will be considered exclusionary; a participant with a history of mild to moderate mood disorder may be included in the study under the discretion of the Investigator. Other stable psychiatric conditions are permitted at the discretion of the Investigator (e.g., attention deficit hyperactivity disorder, generalized anxiety disorder, etc.).\n* Participant has a current or recent history of clinically significant suicidal ideation within the past 6 months, corresponding to a score of 3 or higher (active suicidal ideation with some intent to act, without specific plan) on the Columbia Suicide Severity Rating Scale (C-SSRS), or a history of suicidal behavior within the past year, as validated by the C-SSRS at screening or Day 1.\n* Participant has met DSM-5 criteria for a substance abuse disorder within the last 6 months prior to Screening, except for disorders related to caffeine or nicotine.\n* Participant has a positive test for an illicit drug or cannabis at Screening or Baseline. Participants who test positive for cannabis and who have a valid prescription may be rescreened if they agree to abstain from the cannabis for the length of their participation in the study. The repeat test must be negative for them to participate in the study.\n* Participant is taking a serotonin reuptake inhibitor or antipsychotic medication.\n* Participant has had a change to psychotropic medications within the last 2 months\n* Participant has received electroconvulsive therapy (ECT) in the last 6 months.\n* Participant has received new-onset psychotherapy or has had a change in the intensity of psychotherapy within the 2 months prior to Screening.\n* Participant has known allergies, hypersensitivity, or intolerance to Pimavanserin or its excipients.\n* Participant has received an investigational drug or used an investigational medical device within 3 months before the planned start of study or is currently enrolled in an investigational study.\n* Participant has a body mass index (BMI) \\\u003C17 or \\>40 at Screening.\n* Participant has a known history of long QT syndrome or family history of sudden death.\n* Participant has a history of myocardial infarction, unstable angina, acute coronary syndrome, or cerebrovascular accident (CVA) within the last 4 months. Has greater than NYHA Class 2 congestive heart failure or Class 2 angina pectoris, sustained ventricular tachycardia (VT), ventricular fibrillation, torsade de pointes, or syncope due to an arrhythmia.\n* Participant has a history of neuroleptic malignant syndrome\u002Fserotonin syndrome.\n* Participant has had a seizure within the past 12 months. Individuals with seizure disorders who are on stable seizure medications (i.e., without seizures in the past 12 months) are permitted at the discretion of the Investigator.\n* Participant is pregnant or breast-feeding, or planning to become pregnant or breastfeed while enrolled in this study or within 3 months after the last dose of study drug.\n* Participant has current evidence, or a history within the previous 3 months prior to screening, of a serious and\u002For unstable neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, that, in the opinion of the Investigator, would jeopardize the safe participation of the Participant in the study.\n* Participant has a history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the Investigator, is considered cured with minimal risk of recurrence).\n* Participant has a known history of a positive hepatitis C virus (HCV) or human immunodeficiency virus (HIV) test.\n* Participant has a Screening or Baseline ECG with a QTcF\\>450ms when the QRS duration is \\\u003C120 ms or has a Screening or Baseline ECG with a QTcF\\>470 ms when the QRS duration is \\>120 ms.\n* Participant has laboratory evidence of hypothyroidism at Screening, as measured by thyroid stimulating hormone (TSH) and reflex free thyroxine (T4). If TSH is abnormal and the reflex free T4 is normal, the Participant may be enrolled.\n* Participant has current unstable diabetes or glycosylated hemoglobin (HbAIc) \\>8% at Screening.\n* Participant has other clinically significant laboratory abnormalities that, in the opinion of the Investigator, would jeopardize the safe participation of the study Participant.","12 Years","40 Years",{"count":20,"type":21},[230],"This Phase 2 study examines the safety, tolerability, and preliminary efficacy of pimavanserin in individuals with Autism Spectrum Disorder. Male or female participants aged 12 to 40 years of age will be randomized to receive single doses of either placebo or pimavanserin in this randomized, placebo-controlled, cross-over designed study, followed by open label extension.",[444],"Autism Spectrum Disorder",[446,447,448,449,450,451,452,444,453],"Pimavanserin","Nuplazid","Antiparkinson Agents","Antipsychotic Agents","Serotonin 5-HT2 Receptor Antagonist","Physiological Effects of Drugs","Serotonin Agents","Autistic Disorder","2026-03-26",{"date":456,"type":39},"2026-04-01",{"date":458,"type":39},"2025-10-01",{"date":429,"type":21},{"name":45,"class":46},{"id":462,"slug":463,"hasResults":11,"nctId":464,"briefTitle":465,"officialTitle":466,"acronym":4,"eligibilityCriteria":467,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":367,"enrollmentInfo":468,"targetDuration":4,"studyType":22,"phases":469,"briefSummary":470,"conditions":471,"keywords":475,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":485,"lastUpdatePostDateStruct":486,"startDateStruct":488,"completionDateStruct":489,"leadSponsor":491,"locationsCount":4},"100471268","shared-decision-making-for-antipsychotic-medications-100471268","NCT05416658","Shared Decision Making for Antipsychotic Medications","Examining the Effectiveness of a Shared Decision Making Intervention for Antipsychotic Medications to Improve Engagement in Treatment for People Experiencing Early Psychosis","Inclusion Criteria:\n\n* Ages 18 to 30 who have experienced nonaffective psychosis with a diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, other specified\u002Funspecified schizophrenia spectrum and other psychotic disorders (ICD-10-CM Diagnosis Code F20.x)\n* Current\u002Fpast experiences with antipsychotic medications (APM; e.g., currently taking any antipsychotic medication, stopped taking, or considering stopping).\n* Receive FEP treatment in one of OnTrackNY clinics\u002Fsites randomized to intervention or treatment as usual (TAU) - Willing to participate in research interviews after each APM visit during the study period (3 months)\n\nExclusion Criteria:\n\n* Unable to provide informed consent\n* No experience with APM\n* Not fluent (speaking, reading, writing) in English",{"count":58,"type":21},[81],"This study aims to provide an evidence-based shared decision making intervention for antipsychotic medications, the Antipsychotic Medication Decision Aid (APM-DA), for individuals experiencing early psychosis and provide, for the first time, an understanding of the shared decision making mechanism of action.",[260,28,472,473,474],"Schizophreniform Disorders","Delusional Disorder","Other Specified Schizophrenia Spectrum and Other Psychotic Disorder",[476,477,478,479,480,481,482,483,484],"Shared decision making","psychosis","schizophrenia","antipsychotic","medication","intervention","decision aid","coordinated specialty care (CSC)","randomized controlled trial (RCT)","2026-03-24",{"date":487,"type":39},"2026-03-30",{"date":245,"type":21},{"date":490,"type":21},"2027-06-30",{"name":45,"class":46},{"id":493,"slug":494,"hasResults":11,"nctId":495,"briefTitle":496,"officialTitle":497,"acronym":4,"eligibilityCriteria":498,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":324,"enrollmentInfo":499,"targetDuration":4,"studyType":22,"phases":500,"briefSummary":501,"conditions":502,"keywords":504,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":509,"lastUpdatePostDateStruct":510,"startDateStruct":511,"completionDateStruct":512,"leadSponsor":514,"locationsCount":47},"100603637","phase-4-understanding-the-role-of-the-kappa-opioid-receptor-in-ketamines-attenuation-of-suicidal-thoughts-100603637","NCT07139106","Understanding the Role of the Kappa Opioid Receptor in Ketamine's Attenuation of Suicidal Thoughts","Dynorphin\u002FKappa Opioid Receptor Signaling Role in Ketamine's Anti-suicidal Ideation Effect","Inclusion Criteria:\n\n* DSM5 unipolar major depressive episode\n* Persons of child-bearing potential must agree to use an acceptable method of birth control throughout the study.\n\nExclusion Criteria:\n\n* Current or past ketamine abuse or dependence ever (lifetime)\n* Any medical contraindication to ketamine, including prior ineffective trial of or medically significant adverse reaction to ketamine.\n* Clinically significant EKG abnormality in terms of ketamine administration (e.g., Ventricular tachycardia, evidence of myocardial ischemia, symptomatic bradycardia, unstable tachycardia, second degree (or greater) AV block).\n* Lifetime schizophrenia, schizoaffective illness, bipolar disorder, current psychotic depression; mild drug or alcohol use disorder in past 2 months; moderate or severe drug or alcohol use disorder in past 6 months; suicidal ideation with plan and\u002For intent within 6 months; suicide attempt in the past month.\n* A first-degree family history of schizophrenia if the subject is less than 33 years old (mean age of onset for schizophrenia plus two standard deviations).\n* Current or recent use of antidepressants within 14 days or benzodiazepines within 1 day. Use of fluoxetine or other long-acting antidepressant within 6 weeks.\n* Current or recent use of medications known to affect brain biology of interest such as competing for binding sites of PET tracer within 1 month.\n* Uncontrolled moderate or severe hypertension (≥160 mmHg systolic or ≥100 mmHg diastolic\\[41\\]), history of Raynaud's phenomenon, seizures, an open cut, sore, or bone fracture on or near the hands to be used for the cold pressor test.\n* Use of more than incidental NSAIDs (including aspirin), anti-inflammatories, immune suppressants or other pain medications.\n* Significant active physical illness, particularly if it may affect the brain biology being studied; including chronic pain syndrome and medically compromising eating disorders or epilepsy.\n* Lacks capacity to consent\n* Aggressive behavior that is a significant threat to others such as physically assaultive behavior (in the last month).\n* Pregnancy, abortion or miscarriage in the previous two months or plans to conceive during the course of study participation.\n* Currently lactating\n* Previous head injury with evidence of cognitive impairment. Subjects who endorse a history of prior head trauma and score 1.5 standard deviations below the mean on Trail-making A or B will be excluded from study participation.\n* Any condition or material in the body that is a contraindication for MRI procedures.\n* Current, past or anticipated exposure to radiation except if the exposure was at our PET center where the precise exposure is known\n* ECT within past 6 months\n* For A-Line Subjects: Unstable relevant medical condition (i.e., condition not adequately stabilized for 3 months). Including bleeding disorders, the need to take medications that affect blood clotting, and certain platelet and hemoglobin cutoffs\n* Blind or with visual impairment that cannot be corrected with corrective lenses (glasses or contact lenses)\n* No emergency contact",{"count":343,"type":21},[24],"This study explores how stress, suicidal thoughts, and ketamine's effects are connected in people with major depressive disorder. Stress increases the risk for suicidal thoughts, but the biological basis is unclear. Ketamine may help reduce suicidal thoughts by affecting stress-linked brain systems. This study will use smartphone tracking to monitor real-time responses to stress and positron emission tomography (PET) brain scans to study how ketamine affects brain pathways related to stress and suicidal thoughts in depressed individuals.",[503],"Major Depressive Disorder (MDD)",[505,506,507,508],"ketamine","positron emission tomography (PET)","kappa opioid receptor","major depressive disorder (MDD)","2026-03-23",{"date":485,"type":39},{"date":410,"type":21},{"date":513,"type":21},"2028-05-01",{"name":45,"class":46},{"id":516,"slug":517,"hasResults":11,"nctId":518,"briefTitle":519,"officialTitle":520,"acronym":4,"eligibilityCriteria":521,"healthyVolunteers":11,"sex":522,"minAge":17,"maxAge":523,"enrollmentInfo":524,"targetDuration":4,"studyType":22,"phases":526,"briefSummary":527,"conditions":528,"keywords":529,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":533,"lastUpdatePostDateStruct":534,"startDateStruct":536,"completionDateStruct":538,"leadSponsor":540,"locationsCount":47},"100509853","effects-of-rtms-on-food-choice-in-anorexia-nervosa-100509853","NCT05918835","Effects of rTMS on Food Choice in Anorexia Nervosa","Deciphering the Neural Mechanisms of Restrictive Eating in Anorexia Nervosa Using Repetitive Transcranial Magnetic Stimulation","Inclusion Criteria:\n\n* DSM-5 Diagnosis of Anorexia Nervosa\n* Age 18-30 years\n* Female\n* Right-handed\n* Body Mass Index (BMI) ≥ 16.0\n* Voluntarily admitted to inpatient eating disorders unit at NYSPI\n* Competent to provide informed consent\n* English-speaking\n* Medically stable\n\nExclusion Criteria:\n\n* High risk of suicide\n* Current substance use disorder or other co- morbid psychiatric condition requiring specialized treatment (e.g., psychosis)\n* Diagnosis of major medical or neurological problem or taking medication that significantly increases risk for seizure or affects interpretation of findings (e.g., unstable hypertension, seizure disorder)\n* Food restrictions (e.g., allergies) which impact greater than 30% of food choice task's choice options\n* Indwelling ferromagnetic metallic object (e.g., pacemaker, pump), non- removable metal jewelry, medicinal patch or recent metallic ink tattoo\n* History of seizure\n* Diagnosis of epilepsy, stroke, multiple sclerosis, traumatic brain injury, Alzheimer's and other neurodegenerative diseases, meningoencephalitis or intracerebral abscess, or parenchymal or leptomeningeal cancers\n* Prior exposure to TMS\n* Pregnancy\n* Currently breast-feeding\n* Significant claustrophobia\n* Implanted devices or stimulators\n* Hearing loss (e.g., currently undergoing treatment with ototoxic medications or those with cochlear implants)","FEMALE","35 Years",{"count":525,"type":21},72,[81],"This study will examine the impact of high-frequency repetitive transcranial magnetic stimulation on food choice behavior and related neural activity.",[167],[530,167,531,532],"Repetitive Transcranial Magnetic Stimulation","Restrictive Eating","Feeding and Eating Disorders","2026-02-20",{"date":535,"type":39},"2026-02-23",{"date":537,"type":39},"2023-04-24",{"date":539,"type":21},"2028-06-30",{"name":45,"class":46},{"id":542,"slug":543,"hasResults":11,"nctId":544,"briefTitle":545,"officialTitle":545,"acronym":4,"eligibilityCriteria":546,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":132,"enrollmentInfo":547,"targetDuration":4,"studyType":22,"phases":549,"briefSummary":550,"conditions":551,"keywords":552,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":560,"lastUpdatePostDateStruct":561,"startDateStruct":563,"completionDateStruct":565,"leadSponsor":567,"locationsCount":47},"100555965","phase-2-an-open-trial-of-a-novel-pharmacotherapy-for-habit-modification-in-anorexia-nervosa-100555965","NCT06518941","An Open Trial of a Novel Pharmacotherapy for Habit Modification in Anorexia Nervosa","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form.\n2. Stated willingness to comply with all study procedures and availability for the duration of the study (Clinical interview).\n3. Aged 18-60 years (Clinical interview).\n4. Diagnosed with anorexia nervosa (EDA-5).\n5. BMI ≥ 15 kg\u002Fm2 (Clinical team medical record)\n\nExclusion Criteria:\n\n1. Score of High Risk on the Columbia Suicide Severity Scale (C-SSRS).\n2. Pregnancy (Serum pregnancy test on admission).\n3. Current diagnosis of schizophrenia, schizophreniform disorder, bipolar (type I), or substance use disorder (SCID).\n4. Bradycardia (below 60 bpm) (vital signs measurement by the clinical team)\n5. Corrected QT interval (QTc) greater than 480 ms at baseline (EKG).\n6. Antipsychotic medication (antidepressants at a stable dose are allowed) (clinical interview).\n7. Known allergic reactions to components of the donepezil (e.g., known hypersensitivity to donepezil hydrochloride) (clinical interview).\n8. History of peptic ulcer disease (clinical interview).\n9. History of arrhythmia (clinical interview).",{"count":548,"type":21},10,[230],"The purpose of this study is to test the feasibility and tolerability of donepezil in a small group of patients with anorexia nervosa (AN). Study participants will be receiving care at the New York State Psychiatric Institute Eating Disorders Unit. Study medication will be increased from 1 mg per day to a maximum of 5 mg per day for up to 8 weeks. Participants will be closely monitored for side effects by a research psychiatrist every week, in addition to the regular clinical monitoring they receive during inpatient treatment. The study will also include assessments of habit strength to measure any changes in maladaptive eating habits over the course of the treatment.",[167],[553,554,555,556,557,558,559],"anorexia","anorexia nervosa","donepezil","eating disorders","acetylcholinesterase inhibitor","Acetylcholine","habit","2025-07-09",{"date":562,"type":39},"2025-07-14",{"date":564,"type":21},"2026-06",{"date":566,"type":21},"2027-12",{"name":45,"class":46},{"id":569,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":570,"targetDuration":4,"studyType":22,"phases":571,"briefSummary":25,"conditions":572,"keywords":573,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":574,"lastUpdatePostDateStruct":575,"startDateStruct":577,"completionDateStruct":578,"leadSponsor":579,"locationsCount":47},"100573024",{"count":20,"type":21},[24],[27,28,29,30],[32,33,34],"2025-07-08",{"date":576,"type":39},"2025-07-11",{"date":41,"type":39},{"date":43,"type":21},{"name":45,"class":46},{"id":581,"slug":582,"hasResults":11,"nctId":583,"briefTitle":584,"officialTitle":585,"acronym":4,"eligibilityCriteria":586,"healthyVolunteers":11,"sex":16,"minAge":587,"maxAge":588,"enrollmentInfo":589,"targetDuration":4,"studyType":22,"phases":590,"briefSummary":591,"conditions":592,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":594,"lastUpdatePostDateStruct":595,"startDateStruct":597,"completionDateStruct":599,"leadSponsor":601,"locationsCount":47},"100369018","phase-2-the-role-of-brief-potent-glutamatergic-modulation-in-addressing-problem-drinking-100369018","NCT04084860","The Role of Brief Potent Glutamatergic Modulation in Addressing Problem Drinking","The Role of Brief Potent Glutamatergic Modulation in Addressing Problem Drinking: a Randomized, Controlled Trial","Inclusion Criteria:\n\n1. Active alcohol use disorder, with at least 4 heavy drinking day over the past 7 days (greater than 4 drinks a day for males, greater than 3 drinks for females). In the case of the use of other drugs, alcohol is designated as the primary drug\n2. Physically healthy\n3. No adverse reactions to study medications\n4. 21-70 years of age\n5. Capacity to consent and comply with study procedures, including sufficient proficiency in English\n6. Seeking to reduce or stop alcohol use\n\nExclusion Criteria:\n\n1. Meets DSM IV criteria for current major depression, bipolar disorder, schizophrenia, or any psychotic illness, including substance-induced psychosis\n2. Physiological dependence on another substance, such as opioids or benzodiazepines, excluding caffeine, nicotine, and cannabis\n3. Delirium, Dementia, Amnesia, Cognitive Disorders, or Dissociative disorders\n4. Current suicide risk or a history of suicide attempt within the past year\n5. Inability to safely initiate 24 hours of abstinence from alcohol, as evidenced by CIWA greater than 10 during screening; history of severe withdrawal phenomena over the past 6 months (e.g., inpatient stabilization, withdrawal-related seizure); or self-reported inability to maintain abstinence for 24 hours.\n6. Pregnant or interested in becoming pregnant during the study period\n7. Any of the following cardiac conditions: clinically significant left ventricular hypertrophy, angina, clinically significant arrhythmia, or mitral valve prolapse\n8. Unstable physical disorders which might make participation hazardous such as hypertension (\\>160\u002F90), anemia, active hepatitis or other liver disease (transaminase levels \\\u003C 2-3 X the upper limit of normal will be considered acceptable), epilepsy, or untreated diabetes. Participants reporting HIV+ status will be asked to provide information about their current treatment, including all medications. Participants who are on the antiretroviral ritonavir (Norvir) will be excluded due to the possibility that study medications in combination with this medication may increase the risk of drug-induced hepatitis.\n9. Previous history of misuse or abuse of study medications, and a history of an adverse reaction\u002Fexperience with prior exposure to study medications\n10. Recent history of significant violance\n11. On psychotropic or other medications whose effect could be disrupted by participation in the study","21 Years","70 Years",{"count":58,"type":21},[230],"The proposed project tests the efficacy of glutamate modulators in non-depressed individuals with alcohol use disorder (AUD); the primary hypothesis is that the glutamate modulator being tested reduces heavy drinking days compared to the active control. It also aims to investigate, using a 2 by 2 factorial (2x2) design, the hypothesis that the effects of the glutamate modulator are enhanced when combined with behavioral treatment.",[593],"Alcohol Use Disorder","2023-11-03",{"date":596,"type":39},"2023-11-07",{"date":598,"type":39},"2019-11-08",{"date":600,"type":21},"2024-08-31",{"name":45,"class":46},""]