[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"attention-deficithyperactivity-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:attention-deficithyperactivity-disorder":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,43,76,99,125,152,184,214,240,263],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100524966","phase-2-the-effects-of-cannabigerol-on-attention-deficithyperactivity-disorder-100524966",false,"NCT06115603","The Effects of Cannabigerol on Attention-Deficit\u002FHyperactivity Disorder","CBG and Attention: A Double-Blind, Randomized, Placebo-Controlled Trial Examining the Effects of Cannabigerol on Indicators of Attention-Deficit\u002FHyperactivity Disorder","CBG","1. Between 18 and 55-years-old.\n2. BMI between 18 and 35 kg\u002Fm2.\n3. Score a 4 or above on the Adult ADHD Self-Report Scale (ASRS-v1.1) Symptom Checklist Part A.\n4. Meet diagnostic criteria for ADHD with a current severity rating of at least mild as defined by the DIAMOND.\n5. Are not pregnant or currently breastfeeding.\n6. Have no history of significant allergic condition, hypersensitivity, or allergic reactions to cannabis, cannabinoid medications, hemp products, medium chain triglyceride oil, or peppermint.\n7. Have not used CBG or any other cannabinoid products in the past 30 days.\n8. Willing to abstain from using cannabis or any THC-containing product for the duration of the study.\n9. Have never used a synthetic cannabinoid or cannabinoid analogue (e.g., dronabinol, nabilone), or a synthetic cannabinoid receptor agonist (e.g., spice, k2).\n10. Have not been exposed to any investigational drug or device 30 days prior to screening and you have no plans to take an investigational drug during the study.\n11. Willing to maintain a stable treatment regimen (i.e., no change in current medication use) for the duration of the study.\n12. Not currently taking a prescription medication for ADHD and have not been prescribed a medication for ADHD in the past six months.\n13. Not currently having thoughts of committing suicide\n14. Does not meet criteria for current severe major depressive disorder or a substance use disorder.\n15. Have not been diagnosed with bipolar disorder or psychosis.\n16. Do not have an acute illness, such as a respiratory infection or other illness that would interfere with study participation; not currently taking medication for an acute illness (e.g., antibiotic).\n17. Do not have history of diagnosis related to liver function and\u002For significantly impaired liver function (e.g., cirrhosis of the liver, hepatitis).\n18. Willing to ensure they have used effective contraception (for example, oral contraception, double barrier, intra-uterine device) for 30 prior to the study and for 30 days after study completion.\n19. Have access to a ride to the University of Arkansas campus for research appointments.\n20. Willing to comply with current university mandates as they pertain to COVID-19 protocols (e.g., mask wearing).\n21. Do not have any serious or unstable physical health conditions including neurological or renal illness.\n22. Do not have any current or historical cardiovascular conditions, including hypotension, bradycardia, or heart block.\n23. No atrial fibrillation, bradycardia, or tachycardia detected via mobile electrocardiogram during the in-laboratory visit.\n24. No recent illicit drug use other than cannabis, or alcohol use in the 12 hours preceding the in-laboratory visit.\n25. Not currently prescribed or taking the following medications:\n\n    * Warfarin\n    * Clobazam\n    * Valproic acid\n    * Phenobarbital\n    * Mechanistic Target of Rapamycin \\[mTOR\\] Inhibitors\n    * Oral tacrolimus\n    * St. John's wort\n    * Epidiolex\n    * Escitalopram\n    * Cardiovascular medications\n    * Strong CYP3A4 inhibitors (e.g., ketoconazole)",true,"ALL","18 Years","55 Years",{"count":22,"type":23},76,"ESTIMATED","INTERVENTIONAL",[26],"PHASE2","The goal of this clinical trial is to evaluate the effects of Cannabigerol (CBG) on indicators of Attention-Deficit\u002FHyperactivity Disorder (ADHD) in a sample of participants indicating\u002Freporting symptoms associated with ADHD. The main question it aims to answer is: Does CBG reduce ADHD-related indicators relative to placebo? Participants will administer an acute dose of placebo or 80mg CBG and complete outcome measures at 45 minutes and 75 minutes. Daily surveys to monitor safety will be administered for one week following administration.",[29],"Attention-Deficit\u002FHyperactivity Disorder","RECRUITING","2026-05-22",{"date":33,"type":34},"2026-05-27","ACTUAL",{"date":36,"type":34},"2024-12-14",{"date":38,"type":23},"2026-07",{"name":40,"class":41},"University of Arkansas, Fayetteville","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":17,"sex":18,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":24,"phases":55,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100573218","a-pilot-study-of-a-remote-adhd-monitoring-program-100573218","NCT06743425","A Pilot Study of a Remote ADHD Monitoring Program","A Pilot Study of a Remote Attention-Deficit\u002FHyperactivity Disorder Monitoring Program (RAMP) for Children in Rural Areas","RAMP","Inclusion Criteria:\n\nThe child must\n\n* be under the care of a participating provider\n* be aged 5-11 at enrollment\n* have a diagnosis of ADHD\n* be initiating stimulant medication for treatment for the first time or have not received stimulant medication for the last 6 months\n* be attending in-person elementary school\n\nThe Primary caregiver must\n\n* be willing and legally able to give consent\n* have access to a smartphone\n* be English-speaking\n* reside with the child at least 3 days per week\n* complete an initial symptom assessment prior to starting stimulant treatment and be willing to provide a copy to the study team\n\nThe provider must\n\n* manage ADHD care in patients age 5-11 years\n* provide informed consent\n* agree to use the RAMP platform if they care for patients randomized to use it\n* agree to provide information to potential participants about the study and contact the research coordinator if interested\n\nExclusion Criteria:\n\nChild:\n\n* has serious mental health comorbidities (Children with depression, anxiety, oppositional defiant disorder will be permitted to participate. Children with schizophrenia, bipolar disorder, conduct disorder and those who have been hospitalized for any mental health condition will be excluded from the study.)\n* has severe neurodevelopment disorders (Children with well-controlled seizure disorders will be permitted to participate.)\n* is currently receiving, or previously received, atypical antipsychotic medication treatment\n* is or becomes pregnant","5 Years","11 Years",{"count":54,"type":23},36,[56],"NA","RAMP is a pilot study examining the use of an Attention-Deficit\u002FHyperactivity Disorder (ADHD) Monitoring Program during the early stages of treating ADHD in children living in rural settings. This trial will enroll 36 caregiver\u002Finfant dyads across 2 sites and will evaluate feasibility endpoints rather than clinical outcomes. Enrolled participants will be randomized 1:1 to the intervention group (RAMP reports) or control group (digital education handouts). The study duration is 10 months, including start-up, enrollment and intervention, and data analysis and manuscript submission.",[59,60],"Attention-deficit\u002FHyperactivity Disorder","ADHD",[62,63,64],"Rural health","Vanderbilt","Text-based Symptom Reporting","2026-04-27",{"date":67,"type":34},"2026-04-28",{"date":69,"type":34},"2025-02-04",{"date":71,"type":23},"2026-07-01",{"name":73,"class":74},"IDeA States Pediatric Clinical Trials Network","NETWORK",2,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":24,"phases":85,"briefSummary":87,"conditions":88,"keywords":89,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":42},"100560487","phase-4-an-open-label-treatment-with-randomization-observation-investigator-initiated-study-on-the-duration-and-efficacy-of-jornay-pm-methylphenidate-hydrochloride-extended-release-capsules-on-adult-adhd-symptoms-and-executive-function-and-emotional-regulation-throughout-the-day-into-early-evening-100560487","NCT06577779","An Open-Label Treatment With Randomization Observation, Investigator-Initiated Study, on the Duration and Efficacy of Jornay PM (Methylphenidate Hydrochloride Extended-Release Capsules) on Adult ADHD Symptoms and Executive Function and Emotional Regulation Throughout the Day Into Early Evening","Inclusion Criteria:\n\n1. Adults ages 18-60 years, inclusive at the time of consent\n2. Able to provide signed informed consent\n3. Any gender\n4. Subjects with a current primary Diagnostic and Statistical Manual of Mental Disorders (DSM) -5 diagnosis of ADHD of predominantly inattentive presentation, or combined presentations) as confirmed by the Adult ADHD Clinical Diagnostic Scale (ACDS) Version 1.2.\n5. Subjects who are not receiving any pharmacological treatment for ADHD must have an DSM AISRS 18 item total score of ≥ 28 at screening. Subjects who were previously receiving pharmacological treatment for ADHD at screening must have a minimum total DSM AISRS 18 item score of ≥ 22 at screening\n6. Dysthymia and anxiety disorders in remission, but stable on psychiatric medication for three weeks or more at the discretion of principal investigator will be allowed. Medication for these disorders to remain constant for the duration of the protocol.\n7. Subjects, who have not used stimulant medication in the past 2 months.\n8. Occasional use of marijuana (less than 3 times weekly) will be allowed during screening process until subject is enrolled into the study. After subject is enrolled onto Jornay PM, subject is asked to complete an attestation. The attestation will state that the subject will not consume marijuana while in the study.\n9. No illicit substance will be allowed at screening or during the study.\n\nExclusion Criteria:\n\n1. Known hypersensitivity to methylphenidate, or product components.\n2. Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use of an MAOI within the preceding 14 days.\n3. Lifetime bipolar disorder, psychotic disorders, autism, intellectual disability except mood disorders accepted under the inclusion criteria at the discretion of the principal investigator.\n4. Active suicidality within past year, or history of suicide attempt in past 2 years\n5. Any history of severe past drug dependence determined by the Mini International Neuropsychiatric Interview (MINI) (i.e., a focus of clinical attention or a cause of substantial social or occupational difficulty)\n6. Concurrent substance abuse and\u002For history of substance use within 6 months (except for marijuana use of less than three times a week and\u002For history of excessive marijuana use of less than three times a week within 6 months).\n7. Use of any prescribed benzodiazepine\n8. Any unstable medical or neurological condition; clinically significant medical abnormalities such as cardiovascular abnormalities, and any chronic condition of the central nervous system\n9. Antidepressants and anti-anxiety agents (including benzodiazepines) taken in stable doses will be allowed, while other psychotropic medications, including hallucinogens, mood stabilizers, antipsychotics will not be allowed\n10. Known nonresponse to MPH treatment\n11. History of allergic reaction or sensitivity to MPH\n12. Female of childbearing age, who are breastfeeding, pregnant, planning to be pregnant or men planning to make a woman pregnant during the study or for one-month post study\n13. PI\u002Fclinician discretion","60 Years",{"count":84,"type":23},30,[86],"PHASE4","The goal of this study is to extend the efficacy evidence of sustained release methylphenidate compound (JornayPM) in adults with Attention-deficit\u002Fhyperactivity disorder (ADHD). JornayPM has recently been approved for treatment of patients 6 years and older with ADHD; the release mechanism is unique among ADHD products in that it is taken in the evening, with effects in the morning upon awakening and then throughout the subsequent day. Of note, to date, there is no clinical data as to the tolerability or clinical effects or dosing in adults with ADHD; therefore the primary aim of this trial is to gather the first set of these data.",[59],[60,90],"Adult ADHD",{"date":92,"type":34},"2026-04-29",{"date":94,"type":34},"2025-01-29",{"date":96,"type":23},"2026-10-30",{"name":98,"class":41},"NYU Langone Health",{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":18,"minAge":106,"maxAge":107,"enrollmentInfo":108,"targetDuration":4,"studyType":24,"phases":110,"briefSummary":111,"conditions":112,"keywords":113,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":124},"100422462","phase-4-evaluation-of-spn-812-viloxazine-extended-release-capsule-in-preschool-age-children-with-adhd-100422462","NCT04781140","Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Preschool-age Children With ADHD","A Phase 4, Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of SPN-812 in Preschool-Age Children (4 to 5 Years Old) With Attention-Deficit\u002FHyperactivity Disorder (ADHD)","Inclusion Criteria:\n\n1. Is male or female 4 years 0 months of age to less than or equal to 5 years 9 months of age at Visit 1 (Screening) and considered medically healthy.\n2. Subject's parent(s) or legal guardian(s)\u002Frepresentative(s) is (are) willing and able to provide written informed consent before completing any study related procedures.\n3. Has a primary diagnosis of ADHD according to DSM-IV-TR criteria and confirmed with the Kiddie Schedule for Affective Disorders and Schizophrenia - Present and Lifetime Version (K-SADS-PL).\n4. Has an ADHD-RS-IV-P Total Score of ≥ 28 (males) or ≥ 24 (females) at Visit 1 (Screening) and at Visit 2 (Baseline).\n5. Has a CGI-S score of ≥ 4 (moderate or worse) at Visit 1 (Screening) and at Visit 2 (Baseline).\n6. Has undergone an adequate course of non-pharmacologic treatment or is having symptoms severe enough to warrant pharmacologic treatment without prior non-pharmacologic treatment.\n7. Is participating in a structured group activity (e.g., preschool, kindergarten, sports, Sunday school, summer camp or childcare program) at least 2 days a week during study so as to assess symptoms and impairment in a setting outside the home.\n8. Has not initiated any behavioral intervention\u002Ftherapy within 30 days of Visit 1 (Screening) and does not plan to initiate any new or discontinue any ongoing behavioral intervention\u002Ftherapy during the study (e.g., subject is eligible if behavioral intervention\u002Ftherapy is initiated 30 or more days prior to Visit 1 \\[Screening\\] and continues with a similar duration\u002Ffrequency throughout their study).\n9. Subjects who are on ADHD medication at Visit 1 (Screening), but whose ADHD symptoms are not well controlled on current ADHD medication (e.g., meets Inclusion Criterion #4), meet all other inclusion\u002Fexclusion criteria, and discontinues ADHD medication at least 7 days prior to the day of Visit 2 (Baseline) are eligible to participate.\n10. Has no current condition in the opinion of the Investigator that could confound efficacy assessments, safety assessments or increase participant risk.\n11. Has lived with the same parent(s) or legal guardian(s) or has lived under a shared living arrangement (e.g., joint legal custody) for greater than or equal to 6 months prior to Visit 1 (Screening).\n12. Has a body weight ≥5th percentile for age and sex at Visit 1 (Screening) and Visit 2 (Baseline).\n\nExclusion Criteria:\n\n1. Has a diagnosis at Screening (per K-SADS-PL) of another psychiatric disorder that is considered to be the primary diagnosis rather than ADHD or has a comorbid psychiatric disorder secondary to ADHD that, in the opinion of the investigator (after consulting medical monitor), will likely interfere with study treatment adherence and\u002For impact study results.\n2. Has a current diagnosis of a major neurological disorder. The eligibility of those who have seizures, a history of seizure-like events (e.g., syncope, myoclonus, severe muscle spasms), a family history of seizure disorder (immediate family, i.e., sibling, parent), and\u002For febrile seizures will be assessed on a case-by-case basis after consulting the medical monitor.\n3. History of Bipolar Disorder diagnosed in a first degree relative.\n4. Has global development delay or intellectual disability by medical history.\n5. Has a current diagnosis of a significant (per Investigator's evaluation and\u002For judgement) systemic disease.\n6. Has body mass index \\> 95th percentile for the subject's age and sex at Visit 1 (Screening) or Visit 2 (Baseline).\n7. Has a mean resting systolic and diastolic blood pressure\\* that are both \\>95th percentile for age sex, and height and has a mean resting pulse rate\\* that is \\>95th percentile for age and sex (males: \\>117 bpm; females: \\>122 bpm) at Visit 1 (Screening) or Visit 2 (Baseline). \\* Note: The mean of three measurements while seated.\n8. Has a clinically significant electrocardiogram finding(s) at Visit 1 (Screening).\n9. Is currently taking SPN-812 for ADHD, has previously taken SPN-812 for ADHD, but discontinued due to a lack of efficacy or adverse reactions, or has history of allergic reaction, hypersensitivity or intolerance to viloxazine.\n10. Has an allergy to or cannot swallow pudding and applesauce and cannot swallow intact capsule whole.\n11. Has any food allergy, intolerance, restriction or special diet that, in the opinion of the Investigator, could contraindicate the subject's participation in the study.\n12. Has received any investigational drug within the longer of 30 days or 5 half-lives prior to Visit 2 (e.g., first dose of study medication).\n13. Has a positive urine drug test at Visit 1 (Screening). A positive test for amphetamines is allowed for subjects receiving a stimulant ADHD medication at Screening. The subject will be required to discontinue the stimulant for the duration of the study, beginning at least 7 days prior to Visit 2 (Baseline).\n14. Is using of prohibited concomitant medications including known CYP1A2 substrates (e.g., theophylline, melatonin) during the Screening Period or (anticipated) for the duration of the study.\n15. Any reason that, in the opinion of the Investigator, would prevent the subject from participating in the study.\n16. Has suicidal ideation (\"Yes\" indicated on C-SSRS question 4 or 5) or suicidal behavior (\"Yes\" indicated on C-SSRS for any suicidal behavior) within 6 months prior to or the day of Visit 1 (Screening) or has attempted suicide (\"Yes\" indicated on C-SSRS for lifetime).","48 Months","69 Months",{"count":109,"type":23},286,[86],"This study will evaluate the efficacy and safety of SPN-812 (viloxazine extended release) in children 4 to 5 years of age with ADHD.",[29],[60],"2026-02-16",{"date":116,"type":34},"2026-02-18",{"date":118,"type":34},"2024-03-19",{"date":120,"type":23},"2026-06",{"name":122,"class":123},"Supernus Pharmaceuticals, Inc.","INDUSTRY",47,{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":132,"minAge":19,"maxAge":133,"enrollmentInfo":134,"targetDuration":136,"studyType":137,"phases":4,"briefSummary":138,"conditions":139,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":42},"100618142","fibromyalgia-disease-burden-in-mothers-of-children-with-attention-deficithyperactivity-disorder-100618142","NCT07327775","Fibromyalgia Disease Burden in Mothers of Children With Attention-Deficit\u002FHyperactivity Disorder","Is the Disease Burden of Fibromyalgia Syndrome Higher in Mothers of Children With Attention-Deficit\u002FHyperactivity Disorder? A Prospective Controlled Study","Inclusion Criteria:\n\nInclusion Criteria for Participants with Children Diagnosed with ADHD:\n\n* Being a female aged between 18 and 50 years\n* Having one or more children aged 6-17 years diagnosed with Attention Deficit\u002FHyperactivity Disorder (ADHD) according to DSM-5 diagnostic criteria\n* Having a diagnosis of Fibromyalgia Syndrome (FMS according to the 2016 American College of Rheumatology \\[ACR\\] criteria)\n* Being literate\n\nInclusion Criteria for Participants with Children Without Psychiatric Disorders:\n\n* Being a female aged between 18 and 50 years\n* Having one or more children aged 6-17 years without any psychiatric disorders\n* Having a diagnosis of Fibromyalgia Syndrome (FMS) according to the 2016 American College of Rheumatology (ACR) criteria\n* Being literate\n\nExclusion Criteria:\n\n* Receiving regular pharmacological treatment for Fibromyalgia Syndrome\n* Having an active psychiatric disorder or using psychiatric medication\n* Having a history of infectious disease, chronic inflammatory disease, or malignancy\n* Being pregnant or breastfeeding\n* Having a central or peripheral nervous system disorder (e.g., cerebrovascular disease, multiple sclerosis)\n* Being uncooperative during clinical evaluation\n* Having comorbid conditions that may affect quality of life, including congestive heart failure, chronic kidney disease, chronic liver disease, pulmonary disease, uncontrolled diabetes mellitus, or peripheral vascular disease\n* Having a diagnosis of hypothyroidism or hyperthyroidism\n* Having substance use disorder or alcohol use disorder","FEMALE","50 Years",{"count":135,"type":23},100,"1 Day","OBSERVATIONAL","In this study, the investigators aimed to evaluate the impact of having a child diagnosed with Attention-Deficit\u002FHyperactivity Disorder (ADHD) on parental disease burden in mothers diagnosed with Fibromyalgia Syndrome (FMS).\n\nThe study will include 50 mothers with FMS who have a child diagnosed with ADHD and 50 mothers with FMS who have children without any psychiatric disorders.\n\nAmong mothers of children followed with a diagnosis of ADHD at the Child and Adolescent Psychiatry Outpatient Clinic of Edirne Sultan 1st Murat State Hospital, the presence of widespread body pain will be assessed. Mothers reporting widespread body pain will be referred to the Pain Management Outpatient Clinic of the same hospital for further evaluation for FMS. Mothers diagnosed with FMS will be included in the study group.\n\nThe comparison group will consist of mothers with FMS who have children without any psychiatric disorders. These participants will be selected from patients diagnosed with FMS who present to the Pain Management Outpatient Clinic of Edirne Sultan 1st Murat State Hospital.",[140,141,29],"Fibromyalgia Syndrome","Disease Burden","2026-01-08",{"date":144,"type":34},"2026-01-12",{"date":146,"type":34},"2025-12-26",{"date":148,"type":23},"2026-04-30",{"name":150,"class":151},"Sultan 1. Murat State Hospital","OTHER_GOV",{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":18,"minAge":51,"maxAge":159,"enrollmentInfo":160,"targetDuration":4,"studyType":24,"phases":162,"briefSummary":163,"conditions":164,"keywords":166,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":183},"100611595","a-pilot-study-on-efficacy-of-digital-therapeutic-ndtx-02-for-executive-function-in-children-and-adolescents-with-adhd-or-asd-100611595","NCT07242625","A Pilot Study on Efficacy of Digital Therapeutic NDTx-02 for Executive Function in Children and Adolescents With ADHD or ASD","A Multi-center, Prospective, Compared, Randomized, Evaluator-blinded, Pilot Study to Evaluate the Effectiveness of Digital Therapeutics 'NDTx-02' on Executive Function in Children and Adolescents With Attention-Deficit\u002FHyperactivity Disorder (ADHD) or Autism Spectrum Disorder (ASD)","Inclusion Criteria:\n\n* Children and adolescents aged 5 to 12 years at the time of screening\n* Diagnosed with Attention-Deficit\u002FHyperactivity Disorder (ADHD) or Autism Spectrum Disorder (ASD)\\* by a psychiatrist according to DSM-5 diagnostic criteria\n\n  \\*For ASD, diagnosis can be supported by the Autism Diagnostic Interview-Revised (ADI-R) or the Autism Diagnostic Observation Schedule (ADOS), either version 1 or 2\n* Full-Scale Intelligence Quotient (FSIQ) of 65 or higher\n* Able to use the 'NDTx-02' installed on a tablet, alone or with the assistance of a guardian\n* Able to comply with the recommended application schedule for the investigational device (6 weeks, 30 sessions, 5 times per week)\n* Agree not to add or change any treatment\u002Feducation\u002Frehabilitation programs or medications, including Applied Behavior Analysis (ABA) or cognitive therapy, during the study period (continuation of pre-existing TAU \\[Treatment-As-Usual\\] is allowed)\n* Participant and parent (or legal guardian) voluntarily decide to join the trial and provide written informed consent\n* Participants willing to comply with the clinical trial procedures\n\nExclusion Criteria:\n\n* A risk of clinically significant behavioral problems, emotion regulation problems, psychotic symptoms, self-harm, or other harm at a level that affects the treatment process\n* Severe acute\u002Fchronic medical or mental illness\n* Serious trauma or surgery performed within 4 weeks before the screening date\n* Participants with other disabilities such as severe neurological diseases (e.g. brain lesions, mental disorders, etc.)\n* Participants who are currently participating in another clinical trial or have participated in another clinical trial within 30 days before the screening date\n* Change in the dosage or regimen of medications that may significantly affect cognitive function within 4 weeks prior to the baseline visit\n* Change in participation in treatment\u002Feducation\u002Frehabilitation programs that may significantly affect cognitive function within 4 weeks prior to the baseline visit\n* Participation in a clinical trial of, or prior experience using, cognitive improvement or daily living improvement software within 12 weeks prior to the baseline visit\n* In other cases where the investigator determines that participation in the clinical trial is inappropriate due to ethical reasons or the possibility of influencing the results of the clinical trial","12 Years",{"count":161,"type":23},48,[56],"The purpose of this study is to explore the preliminary safety and effectiveness of the digital therapeutic device 'NDTx-02' in supporting improvements of executive function in children and adolescents diagnosed with Attention-Deficit\u002FHyperactivity Disorder (ADHD) or Autism Spectrum Disorder (ASD).",[29,165],"Autism Spectrum Disorder",[29,165,167,168,169,170,171,172,173],"Digital therapeutics","Executive function","Children","Adolescents","Self-management skills","Cognitive Behavior Therapy","Intervention","2025-11-19",{"date":176,"type":34},"2025-11-21",{"date":178,"type":34},"2025-10-16",{"date":180,"type":23},"2026-08",{"name":182,"class":123},"Neudive Inc.",3,{"id":185,"slug":186,"hasResults":11,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":4,"eligibilityCriteria":190,"healthyVolunteers":17,"sex":18,"minAge":191,"maxAge":192,"enrollmentInfo":193,"targetDuration":4,"studyType":24,"phases":195,"briefSummary":197,"conditions":198,"keywords":199,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":75},"100545010","phase-1-washed-microbiota-transplantation-for-attention-deficithyperactivity-disorder-100545010","NCT06376331","Washed Microbiota Transplantation for Attention-deficit\u002FHyperactivity Disorder","Washed Microbiota Transplantation for Attention-deficit\u002FHyperactivity Disorder and Its Comorbidities","Inclusion Criteria:\n\n1. Children with an established diagnosis of ADHD according to Diagnostic And Statistical Manual Of Mental Disorders Fifth Edition;\n2. Aged 3-17;\n3. Received stable treatments for ≥1 month preceding WMT;\n4. Did not take medications affecting gut microbiota such as antibiotics and probiotics three months before WMT.\n\nExclusion Criteria:\n\n1. Unable to understand the questionnaires or provide informed consent by the guardian;\n2. Diagnosed with a single-gene disorder, psychosis, central nervous system diseases, gastrointestinal diseases including ulcerative colitis, Crohn's disease, celiac disease, or eosinophilic esophagitis;\n3. Had severe comorbidities including cardiopulmonary failure, severe liver, and kidney diseases and cancer;\n4. Accompanied with other life-threatening disorders required emergency treatment;\n5. Unable to tolerate colonoscopy or anesthesia","3 Years","17 Years",{"count":194,"type":23},50,[196],"PHASE1","Attention-deficit\u002Fhyperactivity disorder (ADHD) is a common neurodevelopmental disorder characterized by inattention and hyperactivity-impulsivity. ADHD is often accompanied by oppositional defiant disorder and sleep disturbance, and can increase the risk of other psychiatric disorders, functional impairment in academic and occupational performance. Recently, gut microbiota has been implicated in the ADHD via gut-brain axis. In this study, investigators aimed to evaluate the efficacy of WMT for core ADHD symptoms and its comorbidities using specialized questionnaires for ADHD and investigate the underlying mechanism.",[59],[200,201,202,203,204],"attention-deficit\u002Fhyperactivity disorder","washed microbiota transplantation","fecal microbiota transplantation","sleep disturbance","gut-brain axis","2025-09-03",{"date":207,"type":34},"2025-09-05",{"date":209,"type":34},"2024-04-28",{"date":211,"type":23},"2027-07-01",{"name":213,"class":41},"The Second Hospital of Nanjing Medical University",{"id":215,"slug":216,"hasResults":11,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":4,"eligibilityCriteria":220,"healthyVolunteers":11,"sex":18,"minAge":221,"maxAge":159,"enrollmentInfo":222,"targetDuration":4,"studyType":24,"phases":224,"briefSummary":225,"conditions":226,"keywords":228,"overallStatus":230,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":4},"100596373","phase-4-a-study-to-assess-the-effectiveness-and-safety-of-clonidine-extended-release-onydatm-xr-in-children-with-adhd-and-odd-100596373","NCT07044609","A Study to Assess the Effectiveness and Safety of Clonidine Extended-Release OnydaTM XR in Children With ADHD and ODD","A Phase IV, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Effectiveness and Safety of Clonidine Extended-Release (OnydaTM XR) in Children Aged 6 to 12 Years With Attention-Deficit\u002F Hyperactivity Disorder and Oppositional Defiant Disorder","Inclusion Criteria:\n\n1. Male and female subjects aged 6 to 12 years of age inclusive at time of consent\n2. Meets DSM-5 criteria for ADHD, combined, hyperactive\u002Fimpulsive or inattentive presentation using a clinical interview by an experienced clinician and confirmed with the Mini-International Neuropsychiatric Interview for children and adolescents (MINI-KID)\n3. Meets DSM-5 criteria for Oppositional Defiant Disorder confirmed with the MINI-KID\n4. The subject has a parent or legal guardian who will give written informed consent for the subject to participate in the study\n5. Subject and parent\u002Flegal guardian must be able to speak, read, write, and understand English\n6. Subject and parent\u002Flegal guardian must agree to comply with all protocol requirements\n7. ADHD-RS-5 score of ≥28 at Screening and Baseline if not taking ADHD medications. If taking ADHD medication, must have ADHD-RS-5 score of ≥28 after washout at Baseline\n8. Subject has a CGI-S score of ≥4 at Screening if not taking ADHD medication. If taking ADHD medication must have CGI-S score of ≥4 at Baseline\n9. Subject must live with primary caretaker\u002Frater\n10. Sitting systolic and diastolic blood pressure below the 95th percentile for age, gender, and height\n11. Subject is functioning at age-appropriate level intellectually based on investigator's opinion\n12. If a female has experienced menarche, she must have a negative serum beta human chorionic gonadotropin (hCG) pregnancy test at Screening, a negative urine pregnancy test at Baseline, and agree to be abstinent from sexual activity that could result in pregnancy, or use acceptable contraceptives throughout the entire study\n13. Must be able to discontinue stimulants 7 days prior to Baseline and nonstimulants 14 days prior to Baseline\n\nExclusion Criteria:\n\n1. Subject has a current severe comorbid psychiatric condition (except oppositional defiant disorder \\[ODD\\]) that is controlled (requiring a prohibited medication or behavioral modification program) or uncontrolled. These conditions include comorbid disorders, such as bipolar illness, psychosis, autism spectrum disorder, post-traumatic stress disorder, obsessive-compulsive disorder, substance use disorder, or conduct disorder, that in the opinion of the Investigator, contraindicate treatment with OnydaTM XR, or confound efficacy or safety assessments\n2. Use of another investigational drug in the 30 days prior to screening\n3. Use of anticonvulsants, antidepressants, or antipsychotics in the 30 days prior to screening\n4. History (in the past 12 months) or presence of clinically significant cardiovascular, cerebrovascular, renal, hepatic, gastrointestinal, pulmonary, immunological, hematological, endocrine, or neurological disease, that in the opinion of the investigator, could put the subject at risk if he\u002Fshe participates in the trial, or confound study results\n5. History of presence of suicidal ideation or self-injurious behavior\n6. Subject has orthostatic hypotension or history of hypertension\n7. Subject has clinically significant ECG findings as judged by the investigator.\n8. Subject has a QTc-Fridericia (QTc-F) \\> 450 ms in males or \\> 470 ms in females at screening\n9. Subject has participated in another clinical trial within 30 days prior to screening\n10. Subject has an allergy or intolerance to clonidine or OnydaTM XR\n11. Subject has clinically significant abnormal laboratory values at screening\n12. Subject has a positive drug screen at Screening, except for ADHD medications with a valid prescription\n13. Subject has a positive drug screen at Baseline\n14. Subject is currently considered a suicide risk, has previously made a suicide attempt, or has active suicidal ideation based on the Columbia Suicide Severity Rating Scale. Specifically, any positive response on C-SSRS items 4 or 5 currently at screening, or in the past 12 months, is exclusionary\n15. Subject has a history of a seizure disorder, except for children who have had febrile seizures prior to age 5 years\n16. Subjects who have been treated with clonidine or guanfacine in the past 30 days\n17. History of failure to respond to clonidine or guanfacine\n18. Subject started psychotherapy less than 30 days prior to screening\n\n    \\-","6 Years",{"count":223,"type":23},162,[86],"This is a study to see how safe and effective OnydaTM XR is to treat Attention-Deficit\u002FHyperactivity Disorder (ADHD) in children aged 6 to 12 years who also have Oppositional Defiant Disorder (ODD). The trial will consist of a screening period of up to 28 days; a 35-day double-blind treatment period that includes a one week of the lowest dose of medication (0.1mg) given at bedtime, then three weeks at 0.2 mg, then one week at 0.1 mg and a follow-up phone call one week after stopping study medication. During the screening period, we will determine whether participants qualify to enroll in the study.\n\nApproximately 162 boys and girls aged 6 to 12 years, who are currently diagnosed with ADHD and ODD, are planned to be screened in order to complete approximately 124 subjects.\n\nKey Inclusion\u002FExclusion Criteria Participants will have a main diagnosis of ADHD and comorbid ODD based on a structured interview. They will also be required to have significant problems because of their ADHD and be in good health. They will not be able to take other medications for ADHD or any other mental health problems during the study.\n\nAt the screening visit, participants and their parents will be asked about ADHD, ODD and other mental health symptoms. They will also give blood and urine samples, and complete an electrocardiogram and physical exam. Blood pressure and pulse rate will also be obtained. Parents will complete questionnaires about ADHD, ODD, and sleep.\n\nDuring the second visit, the doctor will ensure that participants continue to qualify for the study. Parents and participants will complete questionnaires. Parents will be shown how to dose the study medication. It is a liquid suspension.\n\nParticipants will be seen weekly and will be asked about changes in health, new medications and parents will complete questionnaires while participants have blood pressure and pulse rate checked.\n\nAt the last in-clinic study visit, participants will also have blood and urine samples taken and, complete an electrocardiogram and undergo a physical exam. Parents will complete questionnaires.\n\nOne week after the last in-clinic visit",[59,227],"Oppositional Defiant Disorder in Children",[229],"ADHD, ODD, oppositional defiant disorder","NOT_YET_RECRUITING","2025-06-23",{"date":233,"type":34},"2025-07-01",{"date":235,"type":23},"2025-07",{"date":237,"type":23},"2026-12",{"name":239,"class":41},"Las Vegas Medical Research, LLC DBA Vector Clinical Trials",{"id":241,"slug":242,"hasResults":11,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":4,"eligibilityCriteria":246,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":247,"enrollmentInfo":248,"targetDuration":4,"studyType":137,"phases":4,"briefSummary":249,"conditions":250,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":42},"100510780","focus-groups-in-ethnically-and-racially-diverse-families-100510780","NCT05930886","Focus Groups in Ethnically and Racially Diverse Families","Focus Groups to Optimize Research Methodology in a Multinutrient Study of Racially and Ethnically Diverse Children With ADHD and Emotional Dysregulation","Inclusion Criteria:\n\n* Adult parents\u002Fcaregivers self-identified as Black or Hispanic\u002FLatino\n* With a family member 6-18 years old with suspected ADHD and\u002For emotional dysregulation, or provide care for, or teach someone who meets these criteria\n* Who have sought or are interested in treatment\n* Willing to discuss child's mental health care needs and provide feedback regarding feasibility study\n* Able to attend focus groups in person\n* Able to communicate in English or Spanish\n* Agree to focus group session audio recording\n\nExclusion Criteria:\n\n* Unwilling to be recorded","80 Years",{"count":84,"type":23},"Focus groups to identify treatment needs and barriers to participation in the planned multinutrient study among racially and ethnically diverse (Black and Hispanic) communities.",[251,252,253],"Attention Deficit\u002FHyperactivity Disorder","Emotional Dysfunction","Irritable Mood","2025-04-01",{"date":256,"type":34},"2025-04-04",{"date":258,"type":34},"2023-04-15",{"date":260,"type":23},"2025-10-04",{"name":262,"class":41},"Oregon Health and Science University",{"id":264,"slug":265,"hasResults":11,"nctId":266,"briefTitle":267,"officialTitle":268,"acronym":269,"eligibilityCriteria":270,"healthyVolunteers":11,"sex":18,"minAge":221,"maxAge":192,"enrollmentInfo":271,"targetDuration":4,"studyType":24,"phases":272,"briefSummary":273,"conditions":274,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":42},"100526322","optimizing-research-with-diverse-families---feasibility-and-acceptability-study-fast-100526322","NCT06133231","Optimizing Research With Diverse Families - Feasibility and Acceptability Study (FAST)","A Feasibility and Acceptability Study (FAST) to Optimize Research Methodology in a Multinutrient Study of Racially and Ethnically Diverse Children With ADHD and Emotional Dysregulation","FAST","Inclusion Criteria:\n\n* Children, ages 6-17 years at enrollment, with suspected or definite ADHD based on parent report in a majority of families that identify as Black or Hispanic or multicultural\n* Meet criteria on Child and Adolescent Symptom Inventory-5 (CASI-5) ADHD scale (6+ symptoms ≥ 2), occurring in \\>1 setting, plus one impairing irritability symptom (≥2) from Oppositional Defiant Disorder (ODD) or Disruptive Mood Dysregulation Disorder (DMDD) subscale\n* Able and willing to swallow up to 8 pills per day\n* Medication free for 2 weeks prior to baseline\n* Willing to use Tasso® OnDemand SST+ to collect blood at home and filter cards to provide urine samples\n* Able to communicate in English\n* Parent\u002Fcare giver identifies child as Black\u002FAfrican American or Hispanic\u002FLatina\u002Fo or more than one race (target 70-100%)\n\nExclusion Criteria:\n\n* Neurological disorders\n* Medical conditions (e.g. cancer, kidney or liver disease, diabetes, hyperthyroidism)\n* Psychiatric conditions requiring hospitalization\n* Allergy to any supplement ingredient\n* In people with a uterus: sexually active, pregnancy or suspected pregnancy\n* Abnormality of mineral metabolism",{"count":84,"type":23},[56],"Evaluate feasibility and acceptability of recruiting Black and Hispanic families for an open label clinical trial of multinutrients while collecting real-time parent-reported child behavior data and collecting at-home biospecimens to explore their potential as biomarkers, in a study of pediatric ADHD.",[251,252,253],"2025-01-14",{"date":277,"type":34},"2025-01-16",{"date":279,"type":34},"2024-01-06",{"date":281,"type":23},"2026-01",{"name":262,"class":41}]