[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"schizophrenia-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:schizophrenia-disorder":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,41,63,91,120,142,168,202,228,254,283,309,335,359],{"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":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100641458","dacc-targeted-temporal-interference-for-negative-and-cognitive-symptoms-in-schizophrenia-100641458",false,"NCT07658898","dACC-Targeted Temporal Interference for Negative and Cognitive Symptoms in Schizophrenia","A Randomized Controlled Trial Exploring the Efficacy of Temporal Interference Stimulation for Negative Symptoms and Cognitive Impairment in Schizophrenia","Inclusion Criteria:\n\n* All of the following criteria must be satisfied for enrolment:\n\n  1. A confirmed diagnosis of schizophrenia established according to the criteria set forth in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5);\n  2. Age between 18 and 65 years, regardless of sex, with completion of at least junior secondary education and the capacity to undergo neurocognitive testing;\n  3. Clinically meaningful negative symptoms, operationalized as a PANSS negative symptom subscale (PANSS-NS) total score ≥ 20 with a rating of ≥ 3 on a minimum of one individual PANSS-NS item ; the PANSS positive symptom subscale score must additionally not exceed 19;\n  4. Objective cognitive impairment evidenced by an age- and sex-adjusted composite z-score of ≤ -1.0 on the Chinese version of the Brief Assessment of Cognition in Schizophrenia (BACS), reflecting performance at least one standard deviation below normative values derived from Mandarin-speaking populations;\n  5. Maintenance on an unchanged antipsychotic regimen - with no modification to medication type or dose - for at least 30 days prior to informed consent and continuing throughout the trial;\n  6. Voluntary agreement to participate, documented by written informed consent following thorough explanation of study objectives and procedures; where applicable, a legally authorized representative may provide or co-sign consent.\n\nExclusion Criteria:\n\n* Individuals will be ineligible if any of the following conditions apply:\n\n  1. A concurrent psychiatric diagnosis requiring active clinical management, including but not limited to major depressive episode or bipolar disorder, or the presence of a comorbid neurological disorder or serious physical illness;\n  2. Current or past substance use disorder, encompassing problematic consumption of alcohol or illicit substances;\n  3. A documented seizure disorder or marked electroencephalographic abnormalities, particularly epileptiform activity;\n  4. Evidence of structural brain pathology, including organic lesions, prior traumatic brain injury, or previous neurosurgical intervention;\n  5. Presence of ferromagnetic implants or any other contraindication to MRI or tTIS exposure, including intracranial metallic clips, implanted cardiac devices, or cochlear implants;\n  6. Current use of glucocorticoids or other pharmacological agents known to meaningfully alter cortical excitability;\n  7. Prior exposure to any neuromodulatory intervention - including modified electroconvulsive therapy (MECT), repetitive transcranial magnetic stimulation (TMS), or transcranial direct current stimulation (tDCS) - within the 30 days preceding enrolment.","ALL","18 Years","65 Years",{"count":20,"type":21},62,"ESTIMATED","INTERVENTIONAL",[24],"NA","This randomized, double-blind, sham-controlled trial aims to evaluate the efficacy and safety of dorsal anterior cingulate cortex-targeted temporal interference stimulation in individuals with schizophrenia. Participants will be randomly assigned to receive either active or sham stimulation for 10 sessions over two consecutive weeks. The primary outcome is the change in negative symptoms, assessed using the Negative Symptom Subscale of the Positive and Negative Syndrome Scale. Cognitive performance, detailed dimensions of negative symptoms, psychosocial functioning, quality of life, and treatment-related adverse events will also be evaluated. Neuroimaging assessments will be conducted before and after the intervention to explore potential neural mechanisms underlying the clinical effects of temporal interference stimulation.",[27],"Schizophrenia Disorder","NOT_YET_RECRUITING","2026-06-23",{"date":31,"type":32},"2026-06-26","ACTUAL",{"date":34,"type":21},"2026-06-30",{"date":36,"type":21},"2027-12-30",{"name":38,"class":39},"Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":40},"100641371","mechanisms-of-sulforaphane-supplementation-in-alleviating-negative-symptoms-and-cognitive-impairment-in-schizophrenia-100641371","NCT07652866","Mechanisms of Sulforaphane Supplementation in Alleviating Negative Symptoms and Cognitive Impairment in Schizophrenia","Inclusion Criteria:\n\n1. Diagnosis of schizophrenia according to DSM-5 criteria.\n2. First-episode or illness duration ≤ 10 years, but currently in a non-acute phase of schizophrenia.\n3. Negative symptoms present for ≥ 6 months prior to study entry. Patients must be outpatients or hospitalized for social reasons rather than symptom exacerbation.\n4. PANSS negative subscale (7 items) total score ≥ 20; at least one negative item score \\> 3; no change \\> 3 points between screening and baseline. PANSS positive subscale items related to agitation (P4 excitement, P6 suspiciousness\u002Fpersecution, P7 hostility, G8 uncooperativeness, G14 poor impulse control) each ≤ 4.\n5. Currently taking ≤ 2 antipsychotic medications.\n6. Antipsychotic regimen remains unchanged during the study period.\n7. No anticipated relocation, transportation difficulties, or access problems that would interfere with study participation.\n8. Able to understand and comply with study procedures, complete all required tests and examinations, communicate well with the investigator, and voluntarily provide written informed consent\n\nExclusion Criteria:\n\n1. Psychiatric symptoms attributable to any other DSM-5 diagnosis besides schizophrenia.\n2. History of substance dependence, or psychotic symptoms caused by other medical conditions.\n3. Calgary Depression Scale for Schizophrenia (CDSS) total score \\> 6.\n4. Barnes Akathisia Rating Scale (BARS) score indicating at least moderate akathisia.\n5. Current or past major physical illness, neurological disorder, or traumatic brain injury affecting brain structure\u002Ffunction.\n6. Suicidal attempt or current suicidal ideation.\n7. Currently receiving antidepressants, mood stabilizers; or use of rTMS, MECT, or systematic psychotherapy within 3 months or for the current episode.\n8. Current use of medications that may affect cognitive function, such as Ginkgo biloba extract, minocycline, selegiline.\n9. Presence of hepatic or renal insufficiency, severe gastrointestinal, respiratory, endocrine, or hematologic disorders, or disorders of absorption or metabolism.\n10. Pregnant or breastfeeding women.","12 Years","45 Years",{"count":50,"type":21},60,[24],"The goal of this randomized, double-blind, placebo-controlled clinical trial with an open-label extension is to evaluate whether sulforaphane can improve negative symptoms and cognitive impairment, and to explore its underlying mechanisms in patients with schizophrenia (aged 12-45 years, both sexes, stable on antipsychotic medication). The study duration includes 12 weeks of double-blind treatment followed by a 12-week open-label extension. In the randomized controlled double-blind phase, a total of 60 participants will be randomized 1:1 to receive either six oral tablets (411 μmol GR) of sulforaphane (SFN group, n = 30) or placebo (placebo group, n = 30) for 12 weeks. In the open-label phase, participants will choose whether to continue taking the drugs originally assigned. The primary outcome is the change in PANSS and BNSS scores during the randomized double-blind phase. Secondary outcomes include changes in brain MRI measures, as well as changes in MCCB, CGI-SI, CGI-GI, PSP, SNS, and SAFTEE scores during the randomized double-blind phase; and changes in PANSS, BNSS, and MCCB scores during the open-label phase.SAFTEE scale, serious adverse event record and blood test will be used for safety monitoring.",[27],"2026-06-17",{"date":56,"type":32},"2026-06-18",{"date":58,"type":21},"2026-06-02",{"date":60,"type":21},"2028-12-31",{"name":62,"class":39},"Second Xiangya Hospital of Central South University",{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":70,"enrollmentInfo":71,"targetDuration":4,"studyType":22,"phases":73,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":40},"100641976","tis-for-improving-cognitive-impairment-in-schizophrenia-100641976","NCT07647380","TIS for Improving Cognitive Impairment in Schizophrenia","Efficacy and Safety of Time Interference Stimulation on Cognitive Impairment in Patients With Schizophrenia","Inclusion Criteria:\n\n* Age 18-50 years old;\n* meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth edition (DSM-5) diagnostic criteria;\n* the diagnosis of schizophrenia is confirmed by the Structured Clinical Interview for DSM-5 (SCID-5);\n* the disease duration does not exceed 8 years;\n* 1-2 antipsychotic drugs are taken, and the treatment dose of antipsychotic drugs was stable for at least 1 week before enrollment. Mood stabilizers, antidepressants, and excessive benzodiazepines (lorazepam when 2 doses exceeded 2 mg\u002Fd) are not allowed;\n* The type of antipsychotic drugs remains unchanged during treatment, and the dose is adjusted by no more than 25%;\n* Impaired functioning in daily activities;\n* The Global Deficit Score (GDS) for the MATRICS Consensus Cognitive Battery (MCCB) reaches 0.5 or above;\n* Agree to participate in this study and provide written informed consent\n\nExclusion Criteria:\n\n* Presence of other psychiatric comorbidities, intellectual disability, obvious mood symptoms, or substance use disorders (other than caffeine and\u002For tobacco);\n* with clear drug-induced extrapyramidal reaction;\n* A history of seizures, meningitis, or encephalitis;\n* with contraindications to transcranial electrical stimulation;\n* History of intracranial tumors or surgery;\n* history of severe head trauma;\n* have received other regimens of electrical or magnetic therapy in 1 month before enrollment.","50 Years",{"count":72,"type":21},50,[24],"This study aims to evaluate the efficacy, safety, and underlying neural mechanisms of TIS targeting the hippocampus in ameliorating cognitive impairment associated with schizophrenia (CIAS). Researchers will compare active TIS to a sham control to see if TIS works to treat CIAS. Participants will receive TIS twice a day for 2 weeks. Their clinical data, including the baseline clinical symptom scale score, cognitive function, E\u002FI imbalance index recorded by EEG, and MRI data, will be collected at baseline, at the end of the 2-week intervention, and 4 weeks after the intervention.",[27,76],"Cognitive Impairments",[78,79,80,81],"schizophrenia","cognitive impairments","temporal interference stimulation","excitatory-inhibitory imbalance","2026-06-09",{"date":84,"type":32},"2026-06-15",{"date":86,"type":21},"2026-05-30",{"date":88,"type":21},"2026-12-30",{"name":90,"class":39},"Central South University",{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":97,"enrollmentInfo":98,"targetDuration":4,"studyType":22,"phases":100,"briefSummary":101,"conditions":102,"keywords":105,"overallStatus":110,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":119},"100626349","a-virtual-reality-mindfulness-application-for-aggression-in-schizophrenia-100626349","NCT07434479","A Virtual Reality Mindfulness Application for Aggression in Schizophrenia","Inclusion Criteria:\n\nTRIPP MBI VR and TAU Distraction Groups have the same inclusion criteria. Participants will:\n\n1. Is willing and able to provide written informed consent to participate in the study, attend study visits, and comply with study-related requirements and assessments.\n2. Fluent in written and spoken English, confirmed by ability to read and understand the informed consent form.\n3. Be on optimized and stable atypical antipsychotic treatment as indicated by no antipsychotic changes in 2 weeks prior to enrollment.\n4. Demonstrate documented evidence of good medication adherence for the 2 weeks prior to enrollment, as determined by electronic medication records review and prescriber reported adherence to prescribed schedule as documented in the participant's medical records.\n5. Have a history of impulsive aggression as assessed by a score of ≥ 4 on any item on Impulsive Aggression Factor (IA) on the Impulsive- Premeditated Aggression Scale (IPAS; Stanford et al., 2003).\n6. Have adequate visual and auditory abilities to complete assessments, see and hear stimuli in the VR\n7. Has a primary diagnosis of schizophrenia using the diagnostic criteria for schizophrenia or schizoaffective disorder, as defined in the SCID-5-RV at the Screening Visit.\n8. Adult or late adolescent, between 18 and 64 years of age at the time of informed consent.\n\nExclusion Criteria:\n\nParticipants will be excluded if they:\n\n1. Have past head trauma\n2. Diagnosed with a neurological disorder\n3. Are pregnant or breastfeeding women as evidenced by the participant's medical record.\n4. Have unstable medical illness that compromises the safety of the patient\n5. Have significant suicidal ideation at screening (as assessed by the Columbia - Suicide Severity Rating Scale (C-SSRS; participant answers \"Yes\" to \"suicidal ideation\" Item 4 (active suicidal ideation with some intent to act, without a specific plan) or Item 5 (active suicidal ideation with a specific plan and intent) on the C-SSRS; Non-suicidal self-injurious behavior is not exclusionary)\n6. Are on Electroconvulsive therapy (ECT) within 6 months of the study, participants with metal in their bodies or who have claustrophobia or who do not pass the criteria in NKI's Magnetic Resonance Safety Questionnaire (MRSQ)\n7. Score \\\u003C 4 on all items on Impulsive Aggression Factor (IA) on the IPAS (Stanford et al., 2003)\n8. Have a violent episode requiring seclusion, restraints, or a prn within the week before screening\n9. Evidence of suboptimal medication adherence in the 2 weeks prior to enrollment, as determined by electronic medication records review, and demonstrated by prescriber reported non- adherence to prescribed schedule. Suboptimal adherence includes missed doses (two of more missed doses within the past 2 weeks) or plasma levels indicating that the participant is not receiving the intended therapeutic dose.","64 Years",{"count":99,"type":21},58,[24],"The study investigates whether a virtual reality-based mindfulness based intervention can reduce impulsive aggression in individuals with schizophrenia or schizoaffective disorder. The primary goal is to evaluate whether mindfulness delivered via VR (MBI-VR) improves emotion regulation and engages the dorsomedial prefrontal cortex (dmPFC), a brain region involved in cognitive control and regulation of emotional responses. The study also examines whether these effects show a dose-related relationship.\n\nParticipants will be randomized to receive different doses of MBI-VR intervention or distraction tasks and will complete repeated mindfulness VR sessions. Brain activity will be measured using functional magnetic resonance imaging (fMRI) during an emotion regulation task, along with clinical assessments of impulsive aggression related symptoms.",[27,103,104],"Schizoaffecitve Disorder","Aggression",[106,78,107,108,109],"mindfulness based intervention","dmPFC","emotion regulation","impulsive aggression","RECRUITING",{"date":112,"type":32},"2026-06-10",{"date":114,"type":21},"2026-06-05",{"date":116,"type":21},"2027-12-31",{"name":118,"class":39},"Manhattan Psychiatric Center",2,{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":127,"enrollmentInfo":128,"targetDuration":4,"studyType":22,"phases":130,"briefSummary":131,"conditions":132,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":119},"100617212","understanding-and-treating-severe-and-resistant-pathological-aggression-using-deep-brain-stimulation-to-treat-resistant-aggression-100617212","NCT07315685","Understanding and Treating Severe and Resistant Pathological Aggression: Using Deep Brain Stimulation to Treat Resistant Aggression","STAR","Inclusion Criteria:\n\n* Aged between 18 and 70 inclusive\n* Patients who have been in isolation in a secure psychiatric unit for at least 50% of the time over a period of more than 6 months prior to inclusion\n* A GAF score \\\u003C21\n* An ICAP score \\\u003C40\n* Other stable medical conditions\n* No contraindications to brain imaging (MRI and CT)\n* No contraindications to taking medication for travel (loxapine and diazepam)\n* No contraindications to surgery\n* Adult who has read and understood the information letter and signed the consent form. A psychiatrist, independent of the study and treatment, will examine the patient and determine their ability to read and understand the consent form before signing. If this is not the case, authorisation may be given by the guardianship judge in accordance with Article L. 1111-6.\n* An adult assisted by their guardian or by the judge who has read and understood the information letter and signed the consent form (if the patient is under guardianship). If the guardian does not wish to give an opinion or make a decision for the patient, the guardianship judge may be consulted in accordance with Article L1223-1.\n* Patients covered by social health insurance (except AME)\n* Women of childbearing age (a woman is considered to be of childbearing age, i.e. fertile, after menarche and until she reaches menopause, unless she is permanently infertile) using at least minimally effective contraception (i.e. at least: oral progestogen-only contraception, where inhibition of ovulation is not the primary mode of action, male or female condoms with or without spermicide, diaphragm, diaphragm or sponge with spermicide) for at least 1 month and throughout the study, as well as a negative urinary pregnancy test for β-HCG at inclusion.\n* Surgically sterile women (hysterectomy, bilateral salpingectomy and bilateral oophorectomy)\n* Menopausal women: Post-menopausal status is defined as the absence of menstruation for 12 months without any other medical cause. Elevated follicle-stimulating hormone (FSH) levels in the post-menopausal interval may be used to confirm post-menopausal status in women who are not using hormonal contraception or hormone replacement therapy. However, in the absence of 12 months of amenorrhoea, a single FSH measurement is insufficient.\n\nFor schizophrenic patients\n\n* All previous treatments have failed, including the combination of clozapine (for at least 6 months with clozapine levels \\> 350 ng\u002FmL) + ECT (minimum 20 sessions)\n* Have had at least two clozapine potentiations among the following: lithium, valproic acid, beta-blockers, other antipsychotics.\n\nFor ASD patients with or without intellectual disability\n\n\\- All recommended psychoeducational measures must have been attempted with failure of the following treatments: risperidone, aripiprazole, clozapine, naltrexone, beta-blockers given for at least three months at the maximum tolerated dose.\n\nExclusion Criteria:\n\n* Minors\n* Contraindications to surgery and anaesthesia\n* Contraindications to the use of the Medical Device (diathermy, certain magnetic resonance imaging procedures, transcranial magnetic stimulation (TMS), (see section 'Contraindications' in the 'Information for Prescribers' manual for the implanted neurostimulator)\n* Contraindications to MRI and CT scans (cardiac or neural pacemakers, ferromagnetic surgical clips, implants and metallic objects, intraocular foreign bodies, pregnancy, claustrophobia, cardiac or neural pacemakers, ferromagnetic surgical clips, implants and metallic objects, intraocular foreign bodies, etc.)\n* Other medical problems interfering with the protocol and surgery\n* Pregnant women","70 Years",{"count":129,"type":21},6,[24],"Physical aggression can be defined as the use of force with the intention of causing physical injury, psychological damage or death. Pathological aggression may be associated with various psychiatric disorders. This symptom can often be improved by prescribing medication, implementing psychoeducational strategies or even electroconvulsive therapy. However, some patients exhibit such severe pathological aggression that they must be institutionalised because they pose a danger to themselves or others. These patients are then hospitalised in a unit for difficult patients (UMD) for enhanced therapeutic care. Despite this maximum level of care, the pathological aggression of a minority of patients persists, leading to a therapeutic impasse, confining the patient to the UMD for many years with social isolation, a collapsed quality of life, and major repercussions for the family. The aim of this project is to use deep brain stimulation, a controlled, reversible, adaptable and low-morbidity neurosurgical method, in six patients with pathological aggression suffering from either schizophrenia (n=3) or autism spectrum disorders (n=3). We hypothesise that the effects of deep brain stimulation (DBS) of the Sano triangle will significantly control the pathological aggression of these six patients.\n\nThis is a pilot study with randomised, crossover, double-blind evaluation. It will also provide answers regarding the safety of using SCP for this indication.",[133,27],"Autism Spectrum Disorder",{"date":135,"type":32},"2026-06-08",{"date":137,"type":21},"2026-07-13",{"date":139,"type":21},"2029-05-08",{"name":141,"class":39},"University Hospital, Rouen",{"id":143,"slug":144,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":149,"sex":16,"minAge":17,"maxAge":150,"enrollmentInfo":151,"targetDuration":4,"studyType":22,"phases":153,"briefSummary":156,"conditions":157,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":4},"100638411","phase-1-a-positron-emission-tomography-pet-study-to-evaluate-dopamine-d2-and-d3-receptor-occupancy-by-sipi6398-100638411","NCT07626034","A Positron Emission Tomography (PET) Study to Evaluate Dopamine D2 and D3 Receptor Occupancy by SIPI6398","An Open-label Positron Emission Tomography (PET) Study to Evaluate Brain Dopamine D2 and D3 Receptor Occupancy by SIPI6398 in Healthy Volunteers and Patients With Schizophrenia","Inclusion Criteria\n\nHealthy Volunteers\n\n1. Participant is aged 18-55 years, inclusive.\n2. BMI between 19.0 and 32.0 kg\u002Fm2, inclusive.\n3. Participant is medically healthy as determined by clinical evaluations including laboratory safety tests, medical history, physical examination, ECG, and vital sign measurements performed at the Screening visit and before administration of the initial dose of study drug.\n4. Participant is willing and able to be confined to an inpatient setting for the study duration, follow instructions, and comply with the protocol requirements.\n5. Participant is capable of providing informed consent.\n\n   * A signed informed consent form must be provided before any study assessments are performed.\n   * Participant must be fluent (oral and written) in English to consent.\n\nPatients with schizophrenia\n\n1. Participant is aged 18-55 years, inclusive.\n2. BMI between 19.0 and 35.0 kg\u002Fm2, inclusive.\n3. Currently meet a diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). Diagnosis and differential will be confirmed by using the Mini International Neuropsychiatric Interview (M.I.N.I) for Schizophrenia and Psychotic Disorders Studies version 7.0.2 at Screening Visit.\n4. The participant is currently stable: the total Positive and Negative Syndrome Scale (PANSS) score ≤ 60, including P7 (hostile) and G8 (not cooperative) scored ≤ 4.\n5. Participant is willing and able to be confined to an inpatient setting for the study duration, follow instructions, and comply with the protocol requirements.\n6. Participant is capable of providing informed consent.\n\n   * A signed informed consent form must be provided before any study assessments are performed.\n   * Participant must be fluent (oral and written) in English to consent.\n\nExclusion Criteria\n\nHealthy Volunteers\n\n1. Women of childbearing potential (WOCBP), or fertile men whose sexual partners are WOCBP, who are unwilling or unable to use at least 1 highly effective method of contraception during the study and for 90 days following the last dose of trial medication. A female participant is considered to be a WOCBP after menarche and until she is in a postmenopausal state for 12 months or otherwise permanently sterile (for which acceptable methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy).\n2. Females who are pregnant, lactating, or less than 90 days postpartum prior to the Screening Visit.\n3. History or presence of any clinically significant illness, such as cardiovascular, neurologic, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine, or psychiatric disease, considered by the investigator.\n4. Risk for suicidal behavior during the study as determined by the investigator's clinical assessment and C-SSRS as confirmed by the following: Answers \"Yes\" to any of the 5 items (C-SSRS - ideation) within the 3 months before Screening or between the Screening and Baseline Visits, or answers \"Yes\" to any of the 5 items (C-SSRS behavior) within the 12 months before Screening or between the Screening and Baseline Visits, or has a history of nonsuicidal, self-injurious behavior in the past 12 months.\n5. History of current hepatitis or acquired immunodeficiency syndrome or carriers of hepatitis B surface antigen (HBsAg) and\u002For anti- hepatitis C virus (HCV) or human immunodeficiency virus (HIV) antibodies or treponema pallidum antibody.\n6. Participants who had any major surgery, any blood transfusion, donation of blood or plasma within 30 days prior to Screening Visit.\n7. Participants with a history of allergy to more than one class of medications or known to be allergic to any components of the study drug or the radioligand.\n\n   Physical and Laboratory Results\n8. Clinically significant abnormal findings on the physical examination, vital signs, 12-lead ECG, or clinical laboratory results.\n9. The following laboratory tests are exclusionary:\n\n   * Neutrophils, absolute \\\u003C= 1000\u002Fmm3\n   * Aspartate Aminotransferase (AST) \\> 1.5 times upper limit of normal (ULN)\n   * Alanine Aminotransferase (ALT) \\> 1.5 times upper limit of normal\n   * Total Bilirubin (TBil) \\> 1.5 times upper limit of normal\n   * Creatinine \\>1.2 times upper limit of normal\n10. Clinically significant abnormal findings on 12-ECG and\u002For evidence of any of the following cardiac conduction abnormalities:\n\n    * Heart rate \\\u003C 50 bpm or \\> 110 bpm (based on the ECG reading)\n    * QTcF interval \\> 450 msec for males and \\> 470 msec for females\n    * Evidence of second- or third-degree atrioventricular block (AVB)\n11. Participants who test positive for drugs of abuse at Screening Visit or Baseline Visit are excluded.\n12. Use of any prescription medications or over-the-counter (OTC) medications, including health supplements, vitamins or herbal remedies within 7 days or within 5 half-lives of the medication, whichever is longer, prior to Baseline Visit.\n13. Participants who would be likely to require prohibited concomitant therapy during the study.\n14. Participants who suffer from claustrophobia.\n15. Participants with magnetic resonance imaging (MRI)-incompatible implants and other contraindications for MRI, such as pacemakers, artificial joints, nonremovable body piercings, tattoos larger than 1 cm in diameter, metal fragments, etc.\n16. Participants who have received a diagnostic or therapeutic radiopharmaceutical within 30 days prior to Screening Visit.\n17. Participation in other research trials involving ionizing radiation within 1 year of the PET scans that would cause the participant to exceed the yearly dose limits for participants.\n18. Severe motor problems that prevent the participant from lying still for PET and MRI.\n19. Within 6 months prior to Screening Visit:\n\n    •\\> 21 cigarettes per day;\n    * consumes more than 300 mg of caffeine per day (5 cups of coffee or equivalent in caffeinated beverages);\n    * for alcohol, an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males), or an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units (females). One unit is equivalent to a half-pint (220 mL) of beer or 1 measure (25 mL) of spirits or 1 glass (125 mL) of wine.\n20. Unwilling or unable to comply with lifestyle considerations.\n21. Participants who received any investigational agent or device in a clinical trial within 90 days prior to Screening Visit.\n22. Participant does not tolerate venipuncture or has poor venous access that would cause difficulty for administration of the radioisotope and for collecting blood samples.\n23. Participant is, in the opinion of the investigator, unsuitable in any other way to participate in this study.\n\nPatients with schizophrenia\n\n1. WOCBP, or fertile men whose sexual partners are WOCBP, who are unwilling or unable to use at least 1 highly effective method of contraception during the study and for 90 days following the last dose of trial medication. A female participant is considered to be a WOCBP after menarche and until she is in a postmenopausal state for 12 months or otherwise permanently sterile (for which acceptable methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy).\n2. Females who are pregnant, lactating, or less than 90 days postpartum prior to the Screening Visit.\n3. Participant has any of the following psychiatric conditions per DSM-5 criteria, as assessed by the M.I.N.I version 7.0.2. Conditions not assessable by the M.I.N.I should be assessed by clinical judgment.\n\n   * Substance use disorder within the past 12 months (other than nicotine, alcohol or caffeine).\n   * Bipolar I or Ⅱ disorder; obsessive-compulsive disorder; post-traumatic stress disorder; neurocognitive disorders; or other psychotic disorders.\n   * Intellectual disabilities.\n   * Any other psychiatric condition that could interfere with participation in the study.\n   * Mild depressive or anxiety symptoms are permitted if, in the opinion of the investigator, they are considered secondary to the diagnosis of schizophrenia and do not require specific pharmacological intervention.\n4. Participants who experience clinical deterioration during the drug-free interval prior to Baseline Visit, such that they require prohibited rescue therapy.\n5. Participant who is judged to be resistant to antipsychotic treatment by the investigator, based on failure to respond to 2 or more marketed antipsychotic agents, given at adequate dose for at least 6 weeks.\n6. Participant have a history of failure to clozapine, or who are responsive only to clozapine treatment.\n7. Risk of violent or destructive behavior.\n8. Risk for suicidal behavior during the study as determined by the investigator's clinical assessment and C-SSRS as confirmed by the following: Answers \"Yes\" to item 4 or 5 (C-SSRS ideation) within the 3 months before Screening or between the Screening and Baseline Visits, or answers \"Yes\" to any of the 5 items (C-SSRS behavior) within the 12 months before Screening or between the Screening and Baseline Visits. Nonsuicidal, self-injurious behavior is not exclusionary.\n9. History or presence of clinically significant:\n\n   * Cardiovascular disease: Unstable angina, myocardial infarction, heart failure, severe arrhythmias, or hypertension.\n   * Pulmonary disease: Chronic obstructive pulmonary disease, asthma, interstitial lung disease, obstructive sleep apnea or active tuberculosis.\n   * Hepatic disease: Cirrhosis, active hepatitis B\u002FC.\n   * Renal disease: Acute kidney injury, end-stage renal disease.\n   * Hematologic disease: Severe anemia, or coagulopathy.\n   * Gastrointestinal disease: Inflammatory bowel disease, gastrointestinal obstruction, or active peptic ulcer.\n   * Endocrine disease: Diabetes, or thyroid pathology (unless the condition has been stabilized with medications for at least the past 90 days prior to Screening Visit).\n   * Immunologic disease: Active systemic autoimmune disorders or primary immunodeficiency.\n   * Dermatologic disease: Severe atopic dermatitis requiring systemic therapy, or active psoriasis.\n   * Neurologic disease: Epilepsy, Parkinson's disease, Alzheimer's disease, multiple sclerosis, residual of stroke, transient cerebral ischemic attacks, or cerebral palsy.\n   * Oncologic disease: Active malignancy except curatively treated carcinoma in situ or basal cell carcinoma within 5 years.\n   * Or any other condition that, in the investigator's judgment, would jeopardize participant safety or study validity.\n10. History of current hepatitis or acquired immunodeficiency syndrome or carriers of HBsAg and\u002For anti-HCV or HIV antibodies or treponema pallidum antibody.\n11. History of neuroleptic malignant syndrome.\n12. Participants who had any major surgery, any blood transfusion, or donation of blood or plasma within 30 days prior to Screening Visit.\n13. Participants with a history of allergy to more than one class of medications, or known to be allergic to any components of the study drug or the radioligand.\n14. Clinically significant abnormal findings on the physical examination, vital signs, 12-lead ECG, or clinical laboratory results, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results.\n15. The following laboratory tests are exclusionary:\n\n    * Neutrophils, absolute \\\u003C= 1000\u002Fmm3\n    * AST \\> 3 times upper limit of normal\n    * ALT \\> 3 times upper limit of normal\n    * TBil \\> 2 times upper limit of normal\n    * Creatinine \\>1.5 times upper limit of normal\n16. Clinically significant abnormal findings on 12-ECG and\u002For evidence of any of the following cardiac conduction abnormalities:\n\n    * Heart rate \\\u003C 50 bpm or \\> 110 bpm (based on the ECG reading)\n    * QTcF interval \\> 450 msec for males and \\> 470 msec for females\n    * Evidence of second- or third-degree AVB\n17. Participants who test positive for drugs of abuse at Screening Visit or Baseline Visit are excluded.\n18. Use of any oral antipsychotic medications within 14 days or within 5 half-lives of the medication, whichever is longer, prior to Baseline Visit.\n19. Participants on intramuscular (IM) depot therapy within 180 days, or within 5 half-lives of the medication, whichever is longer, prior to Baseline Visit.\n20. Except for antipsychotic medications, use of any other psychotropic medications (including but not limited to antidepressants, anxiolytics, hypnotics, mood stabilizers, and cognitive enhancers) within 7 days or within 5 half-lives of the medication prior to the Baseline Visit, whichever is longer, is exclusionary. Exceptions are detailed in Section 5.6 of the protocol.\n21. Use of any moderate or strong cytochrome P450 (CYP) 3A4 inhibitors or CYP3A4 inducers within 7 days or within 5 half-lives of the medication prior to Baseline Visit (whichever is longer), is exclusionary.\n22. Use of electroconvulsive therapy (ECT) within 90 days prior to Screening Visit.\n23. Participants who would be likely to require prohibited concomitant therapy during the study.\n24. Participants who suffer from claustrophobia.\n25. Participants with MRI-incompatible implants and other contraindications for MRI, such as pacemakers, artificial joints, nonremovable body piercings, tattoos larger than 1 cm in diameter, metal fragments, etc.\n26. Participants who have received a diagnostic or therapeutic radiopharmaceutical within 30 days prior to Screening Visit.\n27. Participation in other research trials involving ionizing radiation within 1 year of the PET scans that would cause the participant to exceed the yearly dose limits for participants.\n28. Severe motor problems that prevent the participant from lying still for PET and MRI.\n29. Within 6 months prior to Screening Visit:\n\n    •\\> 21 cigarettes per day;\n    * consumes more than 300 mg of caffeine per day (5 cups of coffee or equivalent in caffeinated beverages);\n    * for alcohol, an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males), or an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units (females). One unit is equivalent to a half-pint (220 mL) of beer or 1 measure (25 mL) of spirits or 1 glass (125 mL) of wine.\n30. Unwilling or unable to comply with lifestyle considerations.\n31. Participants who received any investigational agent or device in a clinical trial within 90 days prior to Screening Visit.\n32. Participant does not tolerate venipuncture or has poor venous access that would cause difficulty for administration of the radioisotope and for collecting blood samples.\n33. Participant is, in the opinion of the investigator, unsuitable in any other way to participate in this study.",true,"55 Years",{"count":152,"type":21},9,[154,155],"PHASE1","PHASE2","This is an open label study in 2 cohorts of healthy volunteers and 1 cohort of patients with Schizophrenia, designed to evaluate the Dopamine D2 and D3 Receptor Occupancy by SIPI6398 at various doses and timepoints.",[27],"2026-05-29",{"date":160,"type":32},"2026-06-04",{"date":162,"type":21},"2026-08",{"date":164,"type":21},"2027-12",{"name":166,"class":167},"Shanghai Zhongze Therapeutics Co., Ltd.","INDUSTRY",{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":172,"acronym":173,"eligibilityCriteria":174,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":175,"enrollmentInfo":176,"targetDuration":4,"studyType":22,"phases":178,"briefSummary":180,"conditions":181,"keywords":190,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":4},"100613164","phase-3-cognitive-strategies-in-early-psychosis-2-100613164","NCT07263022","Cognitive Strategies in Early Psychosis 2","COSTEP 2","Inclusion Criteria:\n\n* Between the ages of 18 and 35\n* Onset of a psychosis spectrum illness (schizophrenia, schizoaffective disorder, schizophreniform disorder, psychosis NOS, bipolar disorder with psychosis, or major depressive disorder with psychosis) within 5 years of enrollment\n* Estimated IQ of 70 or above\n* Proficient at English as determined through interactions with the study team\n* No change in psychiatric medication within a week of enrollment or MRI study visits\n* No clinically significant change in any medications for at least 1 month prior to study participation or MRI study visits, as determined by PI\u002FCo-Is\n\n  * Participants may have minor adjustments in medication doses in the past 30 days, per PI discretion, but may not have had major increases or decreases in doses, or additions or removal of medication within the past 30 days.\n  * Participants are to have no changes to medications in the past 7 days before drug administration (i.e., must have been on a stable dose for at least 7 days prior to receiving the study drug).\n\nExclusion Criteria:\n\nMedical Criteria:\n\n* Presence of the following medical concerns as determined by the study PI:\n\n  * Major neurological disorder\n  * History of a clinically significant head injury with or without prolonged unconsciousness\n  * Any major medical condition that, in the opinion of the PI, would impede participation in the study or would put the participant at additional risk by participating\n* History of any of the following as reported by the participant:\n\n  * Renal impairment, injury, or disease\n  * Hepatic impairment, injury, or disease\n  * Myocardial infarction or heart disease, or endorsement of history of or of cardiac symptoms at intake:\n\n    * Dyspnea\n    * Palpitations\n    * Orthopnea\n    * Pedal oedema\n    * Significant dizziness\n    * Syncope\n    * Claudication\n  * Low white blood cell count, or is diagnosed with leukopenia, neutropenia, or agranulocytosis\n* Presence of unmanaged hypertension (\\>140\u002F90) or elevated resting heart rate (\\>100 bpm)\n* Abnormal clinical laboratory values:\n\n  * uACR \\> 30 mg\u002Fg\n  * creatinine level \\>0.95 mg\u002FdL\n  * AST or ALT \\> 50 U\u002FL\n  * Bilirubin \\> 1.2 mg\u002FdL\n  * Total Protein \\\u003C 6 g\u002FdL\n* Taking a medication or supplement that has a major drug interaction with any study drugs (e.g., ketamine, MAOIs, clomipramine, diazepam, propranolol, warfarin)\n* Allergies to study drugs\n* Is pregnant, planning to become pregnant, or is breastfeeding\n* Cannot pass the visual acuity test\n* Cannot pass the CMRR Subject Safety Screen due to MRI contraindications\n\nMental health criteria:\n\n* Meets criteria for a severe substance or alcohol use disorder within 3 months of enrollment\n* Lifetime history of a stimulant use disorder\n* Current manic episode as determined by the MINI\n* History of psychiatric hospitalization within 3 months of enrollment\n* Meets criteria for clinical risk of suicidal behavior, as defined by:\n\n  * Clinician judgment\n  * A suicide attempt within 3 months of enrollment\n  * Active suicidal ideation at screening or baseline, as indicated by the C-SSRS Screener\n  * Previous intent to act on suicidal ideation with a specific plan and\u002For preparatory acts within 3 months of enrollment, as indicated by the C-SSRS Screener\n* Symptom severity scores in the severe (6) or extremely severe (7) range on the BPRS for the following items: suicidality, disorientation, bizarre behavior, excitement, elevated mood\n* Any other psychiatric symptoms or conditions that, in the opinion of the PI, would impede participation in the study or put the participant at additional risk by participating\n\nOther criteria:\n\n* Unable or unwilling to provide informed consent\n* Unable to demonstrate adequate decisional capacity, in the judgment of the consenting study staff member, to make a choice about participating in the research study\n* Current guardianship\n* Is under civil commitment or under a stay of civil commitment\n* Illiteracy\n* Has engaged in significant cognitive training, in the opinion of the PI, in the last year","35 Years",{"count":177,"type":21},24,[179],"PHASE3","The goal of this clinical trial is to learn more about decision making in psychosis spectrum disorders, like schizophrenia. Participants will be people who have had symptoms of a psychosis spectrum disorder start within the last five years. The investigators will study how two study agents change decision making in people with psychosis, by asking participants to complete some brain games on the computer before and after taking the study agents. The investigators hope to improve our understanding of psychosis to help people in the future. The main research questions are:\n\n* Does a single dose of modafinil change how people with psychosis play the brain games?\n* Does a single dose of d-serine change how people with psychosis play the brain games?\n* Does a single dose of modafinil change brain activity?\n* Does a single dose of d-serine change brain activity?\n\nParticipants will:\n\n* Complete an interview and self-report questionnaires.\n* Complete safety screening activities, like a blood draw, a urine drug test, and an alcohol breathalyzer test.\n* Complete functional Magnetic Resonance Imaging (fMRI) scans. fMRI uses magnets to take pictures of the brain. There will be six scanning appointments in the study, with two scans each. Appointments will be about a month apart.\n* Take a single dose of a study agent during each scanning appointment. The study agent will be taken after the first fMRI. There are three study agents in total: modafinil, d-serine, and a placebo. Each participant will take each study agent twice during the study.\n* Play brain games on a computer that measure decision making, thinking, and problem solving skills",[182,27,183,184,185,186,187,188,189],"Psychosis","Schizoaffective Disorder","Major Depressive Disorder With Psychotic Features","Bipolar Disorder With Psychotic Features","Psychosis NOS","Schizophreniform Disorder","Psychotic Disorder","Cognition",[189,191,192,193],"Decision Making","fMRI","Psychosis spectrum disorders","2026-05-28",{"date":158,"type":32},{"date":197,"type":21},"2026-07-07",{"date":199,"type":21},"2030-04-30",{"name":201,"class":39},"University of Minnesota",{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":4,"eligibilityCriteria":208,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":209,"targetDuration":4,"studyType":22,"phases":211,"briefSummary":212,"conditions":213,"keywords":214,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":40},"100630475","improving-health-literacy-in-patients-with-schizophrenia-spectrum-disorder-100630475","NCT07488156","Improving Health Literacy in Patients With Schizophrenia Spectrum Disorder","The Impact of Health Literacy on the Attitudes Toward Pharmacological Treatment in Patients With Schizophrenia Spectrum Disorder","Inclusion Criteria:\n\n* Patients admitted to the University Medical Center-New Orleans (UMCNO) inpatient behavioral health unit ages 18 and older with a new or previous diagnosis of schizophrenia spectrum disorder outside of substance use disorders\n* Patients must be proficient in English.\n* Patients must have a government issued social security number (required for reimbursement through the university).\n\nExclusion Criteria:\n\n* Patients at UMCNO that are ages 17 or younger\n* Patients with SSD and concomitant intellectual disability, as evidenced by prior documented history on chart review or patients suspected to have intellectual disability or impairment based on clinical interactions\n* Patients with concomitant substance use and documentation of psychosis being resolved after a period of washout and without the use of psychotropic medications\n* Patients unable to complete health literacy assessments, attitude towards treatment assessments, and IQ testing due to severity of symptoms during hospitalization\n* Patients that are not proficient in English\n* Patients that do not have a government issued social security number",{"count":210,"type":21},34,[24],"The Impact of Health Literacy on the Attitudes toward Pharmacological Treatment in Patients with Schizophrenia Spectrum Disorder\n\nThis interventional study is aimed at:\n\n* assessing and improving the health literacy and\n* assessing the attitude towards treatment of patients with schizophrenia spectrum disorders while they are admitted to the inpatient psychiatric unit.",[27,183,182],[215,216,217,218],"Educational interventions","Schizophrenia","Schizophrenia spectrum disorders","Health literacy","2026-03-17",{"date":221,"type":32},"2026-03-23",{"date":223,"type":21},"2026-03-01",{"date":225,"type":21},"2028-01-01",{"name":227,"class":39},"Louisiana State University Health Sciences Center in New Orleans",{"id":229,"slug":230,"hasResults":11,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":234,"eligibilityCriteria":235,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":236,"enrollmentInfo":237,"targetDuration":4,"studyType":22,"phases":239,"briefSummary":240,"conditions":241,"keywords":242,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":40},"100627206","comparison-of-accelerated-intermittent-theta-burst-stimulation-vs-high-frequency-transcranial-magnetic-stimulation-hf-rtms-on-cognitivesymptoms-in-treatment-resistant-schizophrenia-100627206","NCT07445620","Comparison of Accelerated Intermittent Theta Burst Stimulation vs High Frequency Transcranial Magnetic Stimulation (Hf-rTMS) on Cognitivesymptoms in Treatment-resistant Schizophrenia","Comparison of Accelerated Intermittent Theta Burst Stimulation vs High Frequency Transcranial Magnetic Stimulation (Hf-rTMS) on Cognitivesymptoms in Treatment-resistant Schizophrenia: DB-RCT","DB RCT","Inclusion Criteria:\n\n* Diagnosed with treatment-resistant schizophrenia according to TRIIP Consensus criteria\n* Age: 18-60 years\n* Currently receiving clozapine treatment for at least 6 months\n* Attending psychiatry outpatient department at AIIMS Bhubaneswar\n\nExclusion Criteria:\n\n* Currently receiving or recently received ECT\u002FrTMS\u002FtDCS\n* Co-morbid psychiatric, major medical, or neurological disorders\n* History of withdrawal seizures, delirium tremens, or significant head injury\n* Presence of pacemaker or metal in any part of body (excluding mouth)\n* Pregnant or lactating women","60 Years",{"count":238,"type":21},90,[24],"This randomized, double-blind, sham-controlled trial compares three brain stimulation approaches-accelerated intermittent theta burst stimulation (aITBS), high-frequency repetitive transcranial magnetic stimulation (HF-rTMS), and sham stimulation-for treating cognitive deficits in treatment-resistant schizophrenia. Ninety patients receiving clozapine will be randomized 1:1:1 to receive 20 sessions over 4 weeks targeting the dorsolateral prefrontal cortex. The primary outcome is change in cognitive function measured by B-CATS score at 2, 4, and 12 weeks. Secondary outcomes include social cognition, symptom severity, brain metabolism (FDG-PET), and inflammatory biomarkers.",[182,27],[243,244],"rTMS","Cognitive deficit","2026-02-27",{"date":247,"type":32},"2026-03-03",{"date":249,"type":21},"2026-02-15",{"date":251,"type":21},"2029-12-14",{"name":253,"class":39},"All India Institute of Medical Sciences, Bhubaneswar",{"id":255,"slug":256,"hasResults":11,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":260,"eligibilityCriteria":261,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":22,"phases":264,"briefSummary":265,"conditions":266,"keywords":270,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":4},"100627220","medication-adherence-in-severe-mental-illness-a-promotion-program-100627220","NCT07445802","Medication Adherence in Severe Mental Illness: a Promotion Program","Therapeutic Adherence Promotion Program for Severe Mental Illness: the ADHERA Study Protocol","ADHERA","Inclusion Criteria:\n\n* Diagnosis established using ICD-11 clinical criteria \\[15\\].\n* Aged 18 years or older.\n* Registered on the Patient Portal.\n* With an active prescription for antipsychotic drugs in the MUP (Medication Use Profile).\n\nExclusion Criteria:\n\n* Aged under 18 years old.\n* Unable to provide consent for medical or legal reasons.\n* Not registered on the Patient Portal.\n* No active prescription for antipsychotic drugs in the MUP.",{"count":263,"type":21},1640,[24],"People living with serious mental illnesses such as schizophrenia and bipolar disorder often need long-term medication to stay well. However, many patients have difficulty taking medication regularly, which can increase the risk of relapse, hospitalization, and poorer quality of life. Traditionally, treatment adherence has been measured using self-report questionnaires, which may be influenced by memory or social desirability bias.\n\nWith the recent expansion of electronic prescription systems in Spain, it is now possible to objectively verify whether patients collect their medications from the pharmacy. This provides a new opportunity to better understand and support treatment adherence.\n\nThe ADHERA study will evaluate how well digital self-report questionnaires reflect real medication use compared with electronic dispensing records. We will also explore patient characteristics that may be associated with difficulties in medication adherence. Finally, we will test a new online psychoeducational program-including sessions led by mental health professionals and supported by peer-experience contributors-to determine whether it can help improve adherence.\n\nParticipants with schizophrenia or bipolar disorder who are registered in the hospital's digital patient portal and have active antipsychotic prescriptions will be invited to complete brief adherence questionnaires online. Individuals with signs of reduced adherence will then be invited to take part in a telehealth intervention consisting of ten group sessions, where they will receive information, support, and practical strategies to maintain their treatment plan. Medication adherence will be reassessed after six months.\n\nIf successful, this study may help improve how treatment adherence is measured in clinical practice, guide targeted interventions for individuals at higher risk of non-adherence, and provide evidence for scalable telehealth programs that can be easily implemented in other regions and medical conditions",[267,268,269,27],"Treatment Adherence and Compliance","Severe Mental Disorders","Bipolar Disorder (BD)",[271,78,272,273,274],"treatment adherence","bipolar disorder","electronic health records","medication","2026-02-25",{"date":247,"type":32},{"date":278,"type":21},"2026-09",{"date":280,"type":21},"2028-09",{"name":282,"class":39},"Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz",{"id":284,"slug":285,"hasResults":11,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":4,"eligibilityCriteria":289,"healthyVolunteers":149,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":290,"targetDuration":4,"studyType":22,"phases":292,"briefSummary":293,"conditions":294,"keywords":295,"overallStatus":110,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":301,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":40},"100606569","inter-brain-synchrony-in-schizophrenia-100606569","NCT07177261","Inter-Brain Synchrony in Schizophrenia","Inter-Brain Synchrony as a Neural Mechanism of Social Connection in Schizophrenia","Inclusion Criteria:\n\n* sufficient English fluency to comprehend procedures\n* clinical group will include individuals with a DSM-5 diagnosis of schizophrenia who are clinically stable (outpatients, with no hospitalizations 3 months prior to enrollment and no medication changes 1 month prior to enrollment)\n* members of the community without a psychotic disorder, schizophrenia-spectrum disorder, or current major mood disorder, nor history of a first-degree relative with a psychotic disorder.\n\nExclusion Criteria:\n\n* evidence of IQ \\\u003C 70 or developmental disability\n* history of significant neurological disease, serious head injury, or significant current substance use (moderate or severe substance use disorder in the last 3 months, positive urine toxicology screen on the day of assessment, or sedatives\u002Fanxiolytics taken within 12 hours of the assessment)",{"count":291,"type":21},100,[24],"The goal of this clinical trial is to investigate for the first time in people with schizophrenia a neural mechanism that is thought to facilitate the formation of social connections - inter-brain synchrony - in order to improve scientific understanding of the neural mechanisms of social dysfunction in the disorder, and to provide a basis for the development of new and better treatments to improve social functioning and connectedness in the illness. The main questions it aims to answer are:\n\n1. Investigate inter-brain synchrony as a neural mechanism of social connection in schizophrenia\n2. Manipulate social closeness and test for effects on inter-brain synchrony across groups\n\nThe investigators will compare results from people with schizophrenia to a healthy comparison group (controls) who do not have psychotic disorders to see if inter-brain synchrony is greater in controls. Investigators will also compare measures of inter-brain synchrony before and after the social closeness manipulation to see if inter-brain synchrony changes with increasing closeness.\n\nParticipants will:\n\n* Have a clinicial diagnostic interview and be assessed for clinical symptoms\n* Have an EEG recorded while interacting with another person. Participants will first work with the other person to draw a figure, and then tap fingers together. Participants will then either undergo the experimental manipulation to increase social closeness (called, \"fast friends\") or undergo the control condition that does not increase social closeness (called \"small talk\"). Participants will then repeat the drawing and finger tapping assessment.\n* After completing the experimental or control condition, participants will then repeat the procedure with the other condition that was not yet done.\n* Be interviewed on the number and quality of social interactions.",[27],[78,296,297,298,299],"EEG","interbrain synchrony","hyperscanning","social connections","2026-01-30",{"date":302,"type":32},"2026-02-03",{"date":304,"type":32},"2025-12-01",{"date":306,"type":21},"2027-11-30",{"name":308,"class":39},"University of California, Los Angeles",{"id":310,"slug":311,"hasResults":11,"nctId":312,"briefTitle":313,"officialTitle":314,"acronym":315,"eligibilityCriteria":316,"healthyVolunteers":149,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":317,"targetDuration":4,"studyType":22,"phases":319,"briefSummary":320,"conditions":321,"keywords":322,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":328,"startDateStruct":330,"completionDateStruct":331,"leadSponsor":333,"locationsCount":40},"100621790","reducing-mental-health-stigmatization-among-healthcare-workers-and-students-using-a-virtual-reality-protocol-the-virtus-protocol-100621790","NCT07375199","Reducing Mental Health Stigmatization Among Healthcare Workers and Students Using a Virtual Reality Protocol: The VIRTUS Protocol","Reducing Mental Health Stigmatization Among Healthcare Workers and Students Using a Virtual Reality Protocol: The VIRTUS Protocol, a Randomized Controlled Trial","VIRTUS","Inclusion Criteria:\n\n* aged between 18 and 65\n* currently employed as a healthcare professional or enrolled as a advanced-grade student in medicine, nursing, or psychology\n* no history of psychiatric or addictive disorders (except for tobacco dependence)\n* covered by French social security\n* able to provide informed written consent after receiving appropriate information.\n\nExclusion Criteria:\n\n* current or past psychiatric or addictive disorder (except tobacco dependence)\n* use of antipsychotic medication; first-degree family history of schizophrenia; cognitive impairment\n* susceptibility to cybersickness\n* recent (\\\u003C1 year) or acute neurological disorders\n* history of epilepsy\n* known otorhinolaryngologic conditions causing vertigo, nausea or vomiting\n* pregnancy or breastfeeding\n* legal protection measures\n* any condition, in the investigator's opinion that would prevent valid questionnaire completion.",{"count":318,"type":21},128,[24],"Schizophrenia is a chronic psychiatric disorder, frequently associated with stigma, including within healthcare settings, that significantly impairs quality of life and symptoms. Virtual Reality (VR), as an immersive tool, may allow healthy individuals to experience the first-person perspective of a patient undergoing psychotic symptoms. VR exposure may facilitate perspective-taking, fosters empathy, and studies suggest VR could be a valuable tool to reduce stigma. However, the findings remain incomplete, with considerable variation between protocols and no data on implicit stigma. This study is designed to evaluate the effectiveness of a VR protocol simulating psychotic symptoms on explicit and implicit stigma.\n\nMethods and Analysis A randomized controlled trial involving 128 participants will be conducted. Participants will include healthcare workers and students (medicine, nursing, or psychology) recruited from CH Henri Laborit in Poitiers (France), Poitiers University Hospital, CH Nord-Deux-Sèvres in Thouars (France), and the University of Poitiers. Recruitment will take place over a two-year period. Participants will be randomly assigned to either the intervention group or the control group.\n\nThe protocol involves two short VR scenarios. In the intervention condition only, both scenarios will simulate auditory and visual hallucinations and persecutory delusions, to immerse participants in the experience of someone living with schizophrenia. Stigma will be assessed before the VR intervention, immediately afterward, and at one-month follow-up. Assessment will be conducted using self-report scales (Attribution Questionnaire-27 items by Corrigan et al., 2003 (AQ-27), Community Attitudes toward the Mentally Ill, Taylor \\& Dear 1981 (CAMI) and Reported and Intended Behavior Scale by Evans-Lacko et al., 2011 (RIBS) for explicit stigma, and a behavioural test (Implicit Association Task, Greenwald, McGhee et Schwartz en 1998 (IAT)) for the implicit stigma.\n\nThe primary outcome is the reduction in stigma toward individuals with schizophrenia, assessed with the AQ-27 scale, from baseline to the one-month follow-up, comparing the intervention and control groups. The expected result is a greater reduction in stigma in the intervention group compared to the control group. Secondary outcomes include a one-month reduction in implicit associations, immediate post-intervention effects on stigma, changes in self-reported prejudice and discrimination over time.\n\nEthics and Dissemination All participants receive both oral and written information and provided signed informed consent. The study is under review from the French Research Ethics Committee (reference number: 2025-A01472-47). Results will be disseminated through presentations, conferences, and publications in peer-reviewed scientific journals.",[27],[323,324,325,326],"stigma","virtual reality","empathy","implicit associations","2026-01-21",{"date":329,"type":32},"2026-01-29",{"date":223,"type":21},{"date":332,"type":21},"2028-03",{"name":334,"class":39},"Centre Hospitalier Henri Laborit",{"id":336,"slug":337,"hasResults":11,"nctId":338,"briefTitle":339,"officialTitle":340,"acronym":4,"eligibilityCriteria":341,"healthyVolunteers":149,"sex":16,"minAge":17,"maxAge":175,"enrollmentInfo":342,"targetDuration":4,"studyType":343,"phases":4,"briefSummary":344,"conditions":345,"keywords":346,"overallStatus":110,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":352,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":357,"locationsCount":40},"100616712","ketobrain-brain-energy-metabolism-in-schizophrenia-100616712","NCT07309172","KetoBrain: Brain Energy Metabolism in Schizophrenia","Keto-Brain: Cerebral Energy Substrate Metabolism in First-Episode Schizophrenia","Inclusion Criteria:\n\nInclusion criteria for patients with FES\n\n1. Age 18-35 years\n2. Diagnosed with FES (ICD-10: F20)\n3. Able to give informed oral and written consent.\n\nInclusion criteria for healthy controls\n\n1. Age 18-35 years\n2. No mental disorder (ICD-10: F00-99)\n3. Able to give informed oral and written consent.\n\nExclusion Criteria:\n\nExclusion criteria for patients with FES\n\n1. Any coercive measure including patients in forensic psychiatry\n2. In a clinical condition where the treating clinician evaluates that the patient is not able to attend the research study.\n3. Previous use of AP at an antipsychotic dose (except for Risperidone ≤0.5 mg, Abilify ≤2.5 mg, Seroquel ≤50 mg or Zyprexa ≤2.5 mg) for more than 2 continuous weeks in the past year and\u002For 6 weeks over a lifetime\n4. Use of an antipsychotic in the last 3 months before inclusion at a dose greater than:\n\n   4.1 Seroquel\u002FQuetiapine 50 mg 4.2 Risperdal\u002FRisperidone 0.5 mg\n5. Comorbidity: Borderline intelligence or intellectual disability, autism spectrum disorder, decompensated substance use disorder, psychosis induced by a medical condition or psychosis induced by medication or drug use.\n6. Pregnancy, childbirth within the past 6 months, or breastfeeding. Female participants should use an effective contraception.\n7. Contraindications to MRI (metal, severe claustrophobia).\n8. Acute suicidal thoughts (e.g., resulting in hospitalization)\n9. Diabetes mellitus type 1. History of severe head trauma, stroke, chemotherapy or brain surgery. Hypo- or hyperthyroidism. Epilepsy. Systemic glucocorticoid hormone treatment.\n10. Other conditions interfering with participation according to the qualified physician's judgment.\n\nExclusion criteria for healthy controls\n\n1. Previous use of an antipsychotic dose (except for Risperidone ≤0.5 mg, Abilify ≤2.5 mg, Seroquel ≤50 mg or Zyprexa ≤2.5 mg) for more than 2 continuous weeks in the past year and\u002For 6 weeks over a lifetime\n2. Use of AP in the last 3 months before inclusion at a dose greater than:\n\n   1. Seroquel\u002FQuetiapine 50 mg\n   2. Risperdal\u002FRisperidone 0.5 mg\n3. Pregnancy, childbirth within the past 6 months, or breastfeeding. Female participants should use an effective contraception.\n4. Contraindications to MRI (metal, severe claustrophobia).\n5. Diabetes mellitus type 1. History of severe head trauma, stroke, chemotherapy or brain surgery. Hypo- or hyperthyroidism. Epilepsy. Systemic glucocorticoid hormone treatment.\n6. Other conditions interfering with participation according to the qualified physician's judgment.",{"count":210,"type":21},"OBSERVATIONAL","Objective The objective is to recruit antipsychotic-naïve patients at the first diagnosis with a first-episode schizophrenia disorder (FES) to study ketone metabolism of the brain via PET neuroimaging. Participants will undergo PET neuroimaging at baseline before start of antipsychotic treatment and after 4-8 weeks of antipsychotic treatment including an additional clinical follow-up visit after 6 months. In addition, a healthy control group with one baseline visit will be recruited.\n\nStudy design Non-interventional neuroimaging study with pre-defined follow-up visits.\n\nPatients Patients with a FES (ICD-10: F20) aged 18-35 years who are antipsychotic-naïve including age- and sex-matched healthy controls.\n\nSample size This is an observational pilot project. Currently, no studies have measured brain ketone metabolism before and after AP intake. Assuming a 50% dropout rate at follow-up, the investigators aim to recruit 22 patients to obtain 12 full datasets - a sample size commonly used in PET studies. Healthy controls will only have one study day, so no dropouts are expected - aiming at a sample size of 12 healthy controls.\n\nProcedures Patients will be included at the first FES diagnosis. Before inclusion, an interview with the Schedules for Clinical Assessment in Neuropsychiatry (SCAN) interview will validate the diagnosis. At baseline and follow-up (details in the full protocol and Table 1), patients will be rated by use of the 6-item Positive and Negative Syndrome Scale (PANSS-6), the Clinical Global Impression Severity Scale (CGI-S), the Global Assessment of Functioning Scale (GAF), Alcohol Use Disorders Identification Test (AUDIT), Drug Use Disorders Identification Test (DUDIT), Fagerström Test for Nicotine Dependence (FTND), and the Calgary Depression Scale for Schizophrenia (CDSS). The Matrics Consensus Cognitive Battery (MCCB), which consists of 10 cognitive tests, will measure cognition. Heart rate, blood pressure, height, body weight, waist and hip circumference will be recorded. Patients will be treated according to clinical indication, i.e., they will receive routine clinical care at the local psychiatric hospital and participation in this study will not affect the treatment.\n\nFollow-up Patients will be treated and followed according to normal clinical treatment guidelines at the local psychiatric hospitals, which will not be affected by participation. A re-scan will be performed after 4-8 weeks of antipsychotic treatment.\n\nEndpoints The primary endpoints are\n\n1. Brain ketone and glucose metabolism in FES before antipsychotic treatment compared to healthy controls measured via PET\n2. Brain ketone and glucose metabolism in FES after antipsychotic treatment\n\nRisks and Safety Patients will follow treatment-as-usual at their local psychiatric hospital, with the clinicians from the local hospital being responsible for safety monitoring according to local treatment guidelines. Participation in the present study will not delay clinically indicated antipsychotic treatment. Blood sample results will be obtained from the patient's medical record (MidtEPJ) at the study visits to monitor biochemical safety parameters for medical treatment. Between follow-up visits for this study, patients will follow guideline-based safety monitoring at the local psychiatric hospital.\n\nDuring the PET neuroimaging, participants will have two catheters, one arterial and one venous. Vascular puncture can result in a light degree of pain. The risk of infection is negligible.\n\nPET: Injection of the radiotracer may cause slight pain and redness, which should rapidly resolve. The radiotracers \\[15O\\]H2O and \\[11C\\]OHB are radiolabeled versions of their naturally occurring versions, thus sharing their chemical properties. They are given in non-pharmacological doses. \\[18F\\]FDG is an analogue of glucose, given in non-pharmacological dose (\\\u003C1 nanogram). Allergic reactions have been described, but are extremely rare - it has been used routinely in the workup of cancer patients through decades. Ultimately, no pharmacologic or immunologic side effects are to be expected from the radiotracers.\n\nThe amount of radiation to healthy controls will be 4.6 mSv. Since patients have two study days, the total radiation dose to patients will be 9.2 mSv. The mean background radiation in Denmark is approximately 3 mSv per year. Thus, healthy subjects and patients will get approximately 1½ and 3 times the yearly background radiation during the study. In Denmark, the lifetime risk of lethal cancer is approximately 25%. The radioactive dose of 9.2 mSv administered to patients in this study, may increase the risk by 0.05% (from 25% to 25.05%). The radioactive dose of 4.6 mSv administered to healthy controls in this study, may increase the risk by 0.02% (from 25% to 25.02%).\n\nStudy duration 2025-2027.",[27],[216,347,348,349,350],"PET neuroimaging","Brain energy substrate metabolism","Ketone bodies","Glucose","2025-12-15",{"date":353,"type":32},"2025-12-30",{"date":355,"type":32},"2025-04-15",{"date":116,"type":21},{"name":358,"class":39},"Ole Köhler-Forsberg",{"id":360,"slug":361,"hasResults":11,"nctId":362,"briefTitle":363,"officialTitle":364,"acronym":365,"eligibilityCriteria":366,"healthyVolunteers":11,"sex":16,"minAge":367,"maxAge":4,"enrollmentInfo":368,"targetDuration":4,"studyType":22,"phases":369,"briefSummary":370,"conditions":371,"keywords":372,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":377,"lastUpdatePostDateStruct":378,"startDateStruct":380,"completionDateStruct":382,"leadSponsor":383,"locationsCount":4},"100604814","ai-assisted-masticatory-muscle-training-in-patients-with-schizophrenia-100604814","NCT07154407","AI-assisted Masticatory Muscle Training in Patients With Schizophrenia","The Effectiveness of AI-assisted Masticatory Muscle Training on Oral Hygiene, Masticating, and Swallowing in Patients With Schizophrenia","AI-assisted","Inclusion Criteria:\n\n* Psychiatric Outpatient Ward Schizophrenia Diagnosed patient with 20 years or above\n* Without Violence or suicidal tendencies\n* With a self-owned smartphone\n* Able to stabilise the IOPI machine while testing\n* Able to communicate\n\nExclusion Criteria:\n\n* Severe psychiatric symptoms\n* With medical history which affects oral hygiene and masticating function severely (such as stroke, oral cavity-related cancer, periodontitis)\n* Severe cognitive function with a score of less than 16 marks in the MoCA Test\n* Indicated with Motor Neuron Disease\n* Joining multiple Intervention Experiments simultaneously","20 Years",{"count":291,"type":21},[24],"Dysphagia seems to be quite common and potentially severe in schizophrenia, which may lead to acute asphyxia or pneumonia. Dysphagia in schizophrenia could be associated with drug-induced Parkinsonism, dystonia, tardive dyskinesia, dry mouth, excessive saliva, and other complications. Inadequate oral hygiene may lead to the accumulation of plaque, which can cause oral diseases and consequently result in tooth loss. This could be one of the significant factors affecting impaired masticating and swallowing abilities.\n\nAn experimental study with random assignment will be adopted. The participants from 2 hospitals will be assigned to two groups: experimental group (n=50), and control group (n=50). The experimental group will receive 'AI-assisted Masticatory Muscle Training' sessions, each lasting 20 minutes, before each of their three daily meals. The plaque index, Winkle tongue-coating index, dry mouth, repetitive saliva swallowing, saliva flow rate, biting force, tongue pressure, oral frailty, RSST, DDK, and oral care behaviors were assessed at baseline, as well as during the 3-month follow-ups.",[27],[373,365,374,375,376],"Masticatory Muscle Training","Oral Hygiene","Masticate","Swallow","2025-08-26",{"date":379,"type":32},"2025-09-04",{"date":381,"type":21},"2025-09-11",{"date":116,"type":21},{"name":384,"class":39},"Kaohsiung Medical University Chung-Ho Memorial Hospital"]