[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"irritability\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:irritability":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,52,64,85,113,139,177,202,229,260,290,319],{"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":4,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100054178","psychotherapy-for-irritability-in-youth-comparing-active-treatment-to-nonactive-psychoeducation-supportive-psychotherapy-100054178",false,"NCT07640802","Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy","Psychotherapy for Irritability in Youth: Comparing Active Treatment to Non-Active Psychoeducation Supportive Psychotherapy","* INCLUSION CRITERIA FOR YOUTH\n\n  1. Age 8-16.5 years\n  2. Caregiver and\u002For child reports irritability as a primary clinical concern. Specifically, compared to his\u002Fher peers, the child exhibits markedly increased reactivity to negative emotional stimuli that manifests verbally or behaviorally. For example, the child responds to frustration with extended temper tantrums (inappropriate for age and\u002For precipitating event), verbal rages, and\u002For aggression toward people or property.\n\n  2a. Such events occur, on average, at least three times a week.\n\n  2b. This irritability is impairing in at least two of three domains (home, school, peers)\n\n  3\\. Patients must be fluent in English\n\n  3a. Participants must be able to speak and read English. This study evaluates English language, manualized psychotherapies. The intervention materials, therapist and rater training and supervision procedures, fidelity ratings, and primary outcome measure are\n\ncurrently available and validated only in English. Because psychotherapy relies on nuanced verbal exchange, use of translation or interpreters could alter treatment content, affect therapeutic alliance, compromise fidelity, and limit accurate clinical risk assessment. Examining fidelity and alliance\u002Fsupport are our primary and secondary objective in this study. Therefore, enrolling non-English speakers can introduce a confound to these research questions. Restricting enrollment to English-speaking participants is therefore necessary to ensure participant safety and scientific validity in this trial. Critically, this eligibility criterion is based solely on the language requirements of the intervention and study procedures and is not intended to exclude participants on the basis of race or ethnicity or any other factors.\n\n4\\. On the basis of record review and interviews with child and parent, the research team agrees that the child s response to his\u002Fher current treatment is no more than minimal (i.e. CGI-S of 3 or more).\n\n5\\. Must have no planned changes in outpatient psychiatric treatment regimen, which can include psychotropic medications and\u002For psychotherapeutic interventions, two weeks prior to enrollment.\n\nINCLUSION CRITERIA FOR PARENT\n\n1. Parent of a child eligible for this protocol that can attend 12 parent sessions\n2. Fluent in English\n\nEXCLUSION CRITERIA\n\nParticipants will be screened to exclude participants who would not be able to engage in psychotherapy.\n\n1. Active major depressive disorder or history of psychosis, bipolar I disorder, Level 2 or 3 autism spectrum disorder, active severe substance use disorders (within the last month), conduct disorder, have active suicidal intent or plan as detected on screening instruments.\n2. IQ \\\u003C 70\n3. Past or present medical or neurological condition, disease, disorder, genetic finding, or injury that, in the opinion of the Investigator, may significantly increase the potential risks of study participation, reduce or compromise a subject s ability to fully comply with all study requirements for the duration of the study or may compromise the integrity of the data.\n\nEXCLUSION CRITERIA FOR PARENTS\n\n1. IQ \\\u003C 70\n2. Have any serious medical, mental health, or any condition that interferes with participation, such as active psychosis.\n3. Current alcohol or substance use or dependence (excluding nicotine) within the past 3 months of sufficient magnitude to require independent, concurrent treatment intervention (e.g. Antabuse or opiate treatment but not including self-help groups).","ALL","8 Years","17 Years",{"count":20,"type":21},300,"ESTIMATED","OBSERVATIONAL","Background:\n\nIrritability is defined as proneness to anger that may impair a person s ability to function. It is a common reason for why some children need mental health care. Yet no therapies have been developed just to target irritability. Researchers want to compare different types of therapy for irritability.\n\nObjective:\n\nTo test different types of therapy for children and teens with severe irritability.\n\nEligibility:\n\nPeople aged 8 to 16.5 years with severe irritability. Their parents are also needed.\n\nDesign:\n\nParticipants will have 28 study visits in 18 months.\n\nThey will have a baseline visit. They will answer questions about their mood, behavior, and daily life.\n\nAll parents and children will have 12 therapy sessions. Sessions will be once a week; they will last 30 to 60 minutes. Some of the child sessions may be done by telehealth.\n\nEach parent and child will have 1 of 3 therapy types:\n\nExposure therapy (child). Participants will face things that make them angry. A therapist will help them practice managing their anger.\n\nManagement therapy (parent). Therapists will coach parents on ways to manage their child s behaviors.\n\nPsychoeducation\u002Fsupportive psychotherapy (child and\u002For parent). Participants will talk with therapists about their or their child s feelings and behaviors. They will list their problems and goals; build coping skills; learn to relax; improve communication; and work on managing stress.\n\nSessions may be videotaped. Participants may opt out of being recorded.\n\nParticipants will have phone calls every 2 weeks during therapy. They will answer questions about how they are doing. Follow-up calls will continue for 1 year after therapy.",[25,26,27,28],"Irritability","Disruptive Mood Dysregulation Disorder","Oppositional Defiant Disorder","Attention Deficit Hyperactivity Disorder",[25,30,31,32,33,34,35,36,37,38],"Parent Management Training","Psychosocial Treatment","Exposure Therapy","Children","ANGER","Pediatric","Cognitive Behavioral Therapy","Psychoeducation","Supportive Therapy","NOT_YET_RECRUITING","2026-07-10",{"date":42,"type":43},"2026-07-13","ACTUAL",{"date":45,"type":21},"2026-07-16",{"date":47,"type":21},"2037-12-31",{"name":49,"class":50},"National Institute of Mental Health (NIMH)","NIH",1,{"id":53,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":55,"keywords":56,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":63,"locationsCount":51},"100641449",{"count":20,"type":21},[25,26,27,28],[25,30,31,32,33,34,35,36,37,38],"2026-07-01",{"date":59,"type":43},"2026-07-02",{"date":61,"type":21},"2026-07-07",{"date":47,"type":21},{"name":49,"class":50},{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":71,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":73,"conditions":74,"keywords":75,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":79,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":51},"100249912","psychological-treatments-for-youth-with-severe-irritability-100249912","NCT02531893","Psychological Treatments for Youth With Severe Irritability.","Psychological Treatments for Youth With Severe Irritability","* INCLUSION CRITERIA:\n\nInclusion criteria for both Interpretation Bias Training and Cognitive Behavioral Therapy Studies:\n\n1. Age 8-17 years\n2. Must be enrolled into NIMH DIRP protocol 02-M-0021, Characterization and Pathophysiology of Severe Mood and Behavioral Dysregulation in children and youth.\n3. Must meet DSM 5 diagnostic criteria for DMDD which are (for CBT, must meet lifetime history of either DMDD or one of two core DMDD criteria \\[b or c\\]):\n\n   * Must meet all of the following:\n\n     1. Diagnosis must first be made between ages 6-18 years\n     2. Abnormal mood (specifically, anger and\u002For irritability), present at least half of the day most days, and of sufficient severity to be noticeable by people in the child s environment (e.g. parents, teachers, peers).\n     3. Compared to his\u002Fher peers, the child exhibits markedly increased reactivity to negative emotional stimuli that is manifest verbally or behaviorally. For example, the child responds to frustration with extended temper tantrums (inappropriate for age and\u002For precipitating event), verbal rages, and\u002For aggression toward people or property. Such events occur, on average, at least three times a week.\n   * The symptoms in b and c above are currently present and have been present for at least 12 months without any symptom-free periods exceeding two months.\n   * The onset of symptoms must be prior to age 10 years.\n   * The symptoms are severe in at least one setting (e.g. violent outbursts, assaultiveness at home, school, or with peers). In addition, there are at least mild symptoms (verbal aggression) in a second setting.\n4. Patients must be fluent in English\n\n   1. All instruments have not been validated in other languages.\n   2. Psychotherapy will be designed and conducted in English.\n5. On the basis of record review and interviews with child and parent, the research team agrees that the child s response to his\u002Fher current treatment is no more than minimal (i.e. CGI-S of 3 or more).\n6. Must have no planned changes in outpatient psychiatric treatment regimen, which can include psychotropic medications and\u002For psychotherapeutic interventions, two weeks prior to enrollment and throughout the three weeks of training and post-training assessment.\n\nEXCLUSION CRITERIA:\n\nExclusion criteria both Interpretation Bias Training and Cognitive Behavioral Therapy Studies:\n\n1. The individual exhibits any of these cardinal bipolar symptoms:\n\n   1. Elevated or expansive mood.\n   2. Grandiosity or inflated self-esteem.\n   3. Decreased need for sleep.\n   4. Increase in goal-directed activity (this can result in the excessive involvement in pleasurable activities that have a high potential for painful consequences).\n   5. A history of hypomanic or manic symptoms that occurred in distinct episodes lasting more than 1 day.\n2. Meets DSM 5 criteria for schizophrenia, schizophreniform disorder, schizoaffective illness, Autism Spectrum Disorder, or posttraumatic stress disorder.\n3. IQ\\\u003C70\n4. The symptoms are due to the direct physiologic effects of a drug of abuse, or to a general medical or neurological condition.\n5. Meets criteria for alcohol or substance abuse three months prior to enrollment.\n6. Meets DSM 5 criteria for current major depressive disorder. The rationale for the exclusion of youth with MDD is because the two novel interventions being tested are contraindicated for those with major depressive disorder. However, there is no contraindication to participation for those with treated\u002Fresolved or remitted major depressive disorder; only those with a current diagnosis need to be excluded.",{"count":72,"type":21},200,"Background:\n\nWhen children have severe irritability and temper outbursts, they can be so cranky or angry that it leads to problems at home, in school, and with friends. This is called Disruptive Mood Dysregulation Disorder (DMDD) and there have been no psychological treatments developed specifically for children with this problem. Researchers think two forms of therapy, Cognitive Behavioral Therapy (CBT) and Interpretation Bias Training (IBT), might help children with DMDD.\n\nObjective:\n\nTo test two whether IBT and CBT can decrease severe irritability in children and youth.\n\nEligibility:\n\nChildren 8-17 years old with DMDD. Their symptoms must have started before age 10.\n\nDesign:\n\nParticipants will be screened with a review of their symptoms. Parents and participants will answer questions.\n\nParticipants can do only one or both of these treatments if they wish. Those who wish to do both will start with IBT.\n\nParticipants who do CBT will have 12-16 weekly meetings of research talk therapy. A parent will participate in part of the sessions.\n\nParticipants will talk about what makes them irritable and how it affects them. They may be put in situations that might make them annoyed or irritable.\n\nParticipants will rate how intense their irritability is. Parents and participants will complete rating scales, questionnaires, and interviews.\n\nParticipants will do practice activities at home.\n\nParticipants doing IBT will have up to 14 sessions over 10 weeks.\n\nParticipants will view 15 faces, one at a time, on a computer. They will choose if the face looks happy or angry on a computer. Sometimes the computer gives feedback. Participants will complete some sessions at the NIH and some at home.\n\nParticipants and parents answer questions about their progress.",[25],[76,36,33,77],"Interpretation Bias Training","Natural History","RECRUITING",{"date":59,"type":43},{"date":81,"type":43},"2015-11-17",{"date":83,"type":21},"2028-05-08",{"name":49,"class":50},{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":16,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":4,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":102,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":108,"leadSponsor":110,"locationsCount":4},"100643479","the-impact-of-coffee-consumption-immediately-before-a-nap-on-post-nap-grumpiness-100643479","NCT07635303","The Impact of Coffee Consumption Immediately Before a Nap on Post-Nap Grumpiness","A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Assessment of Immediate Pre-Sleep Caffeine Administration on Self-Reported Post-Nap Irritability and Cognitive Fog in Overworked Adults","JAVA-NAP","Inclusion Criteria:\n\nMust look visibly tired by 2:00 PM.\n\nMust have a self-reported history of sighing heavily at emails.\n\nMust be capable of falling asleep under duress.\n\nExclusion Criteria:\n\nPeople who are \"morning people\" and smile before 8:00 AM (excluded due to baseline psychological bias).\n\nInability to tolerate lukewarm coffee.\n\nCurrent employment as a mattress tester.","18 Years","99 Years",{"count":96,"type":21},50,"INTERVENTIONAL",[99],"NA","The purpose of this study is to determine if drinking a hot cup of coffee immediately before taking a 20-minute nap (the \"Caffeine Nap\") reduces the standard \"grumpiness index\" upon waking compared to drinking decaffeinated bean-water.",[25],[103],"Caffeine, Napping, Grumpiness, Office Survival, Espresso","2026-06-03",{"date":106,"type":43},"2026-06-09",{"date":57,"type":21},{"date":109,"type":21},"2028-07-01",{"name":111,"class":112},"Hightower Clinical","NETWORK",{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":120,"sex":16,"minAge":93,"maxAge":121,"enrollmentInfo":122,"targetDuration":4,"studyType":97,"phases":124,"briefSummary":126,"conditions":127,"keywords":128,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},"100553284","early-phase-1-study-brain-mechanisms-of-frustration-with-magnetoencephalography-in-healthy-volunteers-100553284","NCT06484088","Study Brain Mechanisms of Frustration With Magnetoencephalography in Healthy Volunteers","Characterizing the Brain Circuitry and Neural Activity Mediating Frustration","-INCLUSION CRITERIA:\n\nThis study will include adult healthy volunteers.\n\n* Age: 18-55\n* Consent: can give consent\n* Speak and read English\n\n  --The instruments have not been validated in other languages.\n* At the NIH site, previously screened through other NIH protocols such as protocol 01-M-0254, 17-M-0181, and 93-M-0170 and determined eligible as healthy volunteers.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this\n\nstudy:\n\n-Any serious medical condition\n\n* History, physical exam, or laboratory testing including drug abuse screen.\n\n  -Prescription and over-the-counter medications and dietary supplements with psychoactive properties (e.g., St. John's Wort, Melatonin, Valerian)\n\n  -Any condition that interferes with MRI or MEG\\*\\*\n* History\n\n  -Any current psychiatric diagnosis\n* SCID-V, clinical assessment, or history.\n\n  -Pregnancy\n* Pregnancy testing will be done before all MRIs.\n\n  -People who work on night shifts\n* History\n\n  -Drug use\n* Subjects with drug use or positive drug screen more than two years ago are eligible for participation.\n\n  -Need to wear eye glasses to work with computers\\*\n* History\n\n  -Need to wear contact lenses to work with computers\\*\\*,\\*\\*\\*\n* History\n\n  -Dental retainer\\*\\*\n* Subjects wearing removable dental retainers are eligible for participation\n\n  * Eye glasses create artifacts in MEG and their rigid shape does not fit well in the MEG scanner. The MEG core has plastic optometry lenses that can be placed in paper frames. However, the paper frames need to be secured with tape which makes wearing them very uncomfortable, potentially promoting negative emotion and reducing the reliability of facial expression analysis.\n\n    * Only applies to the NIH site.\n\n      * Contact lenses create artifacts that interfere with eye-tracking.",true,"55 Years",{"count":123,"type":21},90,[125],"EARLY_PHASE1","Background:\n\nIrritability can be defined as an unusually strong response to frustration; these responses may include severe temper outbursts and a constant grumpy mood. Irritability is a common symptom of many mental health disorders. Little is known about how the brain responds to frustration, and few treatments are available for this problem. Researchers want to know more about how the brain responds to frustration.\n\nObjective:\n\nTo learn how the brain responds to frustration.\n\nEligibility:\n\nHealthy adults aged 18 to 55 years. They must have been screened through studies 01-M-0254 or 17-M-0181.\n\nDesign:\n\nParticipants will have up to 3 study visits in 2 months. Each visit will last up to 4 hours.\n\nVisit 1: Participants will be screened. They will have a physical exam. They will complete questionnaires about how often and how easily they get angry or grumpy. They will be trained to use a device that measures hand grip.\n\nVisit 2: Participants will have a magnetic resonance imaging (MRI) scan. They will lie on a table that slides into a tube. Padding will hold their head still.\n\nVisit 3: Participants will undergo magnetoencephalography (MEG). A cone with detectors will be lowered over their head while they are seated. The MEG will measure the magnetic fields in the participant s brain both while they are resting and while they are doing the frustration task. For the task, they will hold a grip device in each hand. They will use the devices to pick 1 of 2 doors on a computer screen. The task has 3 parts. The participant s face will be filmed during this task.",[25],[129],"Healthy volunteers, Frustration, Magnetoencephalography","2026-04-28",{"date":132,"type":43},"2026-04-29",{"date":134,"type":43},"2025-02-21",{"date":136,"type":21},"2027-08-31",{"name":49,"class":50},2,{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":145,"eligibilityCriteria":146,"healthyVolunteers":11,"sex":16,"minAge":147,"maxAge":93,"enrollmentInfo":148,"targetDuration":4,"studyType":97,"phases":150,"briefSummary":151,"conditions":152,"keywords":158,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":51},"100636006","a-scalable-trans-diagnostic-intervention-targeting-adolescent-agency-supported-by-conversational-ai-agencia-100636006","NCT07560072","A Scalable Trans Diagnostic Intervention Targeting Adolescent Agency Supported by Conversational AI (AGENCIA)","A Randomized Controlled Trial Protocol of a Scalable Trans Diagnostic Intervention Targeting Adolescent Agency Supported by Conversational AI","AGENCIA","Inclusion Criteria:\n\n* Adolescents aged 12 to 18 years at enrollment.\n* Presence of emotional or behavioral difficulties causing functional interference (e.g., irritability, impulsivity, emotional dysregulation, conflicts at home or school, avoidance).\n* Difficulties compatible with neurodevelopmental profiles, regardless of formal diagnosis.\n* Ability to use digital materials through a personal device and basic reading skills in Spanish.\n* Availability to attend assessments and participate in the intervention and follow-up schedule.\n* Informed consent from caregivers and assent from the adolescent.\n\nExclusion Criteria:\n\n* Acute clinical risk at pre-screening or screening (e.g., imminent self-harm risk, severe agitation, aggression, disorganized behavior, or unsafe behaviors requiring immediate clinical care).\n* Score of \"Severe\" on any of the three HoNOSCA screening items (self-harm, substance-related problems, or bullying\u002Fsocial problems).\n* Uncompensated sensory, motor, or language barriers preventing valid completion of assessments or participation (e.g., severe visual or hearing impairment, significant receptive\u002Fexpressive language difficulties, motor limitations preventing device use).\n* Intellectual disability defined by screening tools: ABAS-II GAC ≤ 70 or Kaufman Brief Intelligence Test Composite Intelligence Quotient ≤ 70.\n* Any condition judged by the clinical team to require immediate alternative care or that would prevent safe participation.","12 Years",{"count":149,"type":21},465,[99],"The aim of this clinical trial is to evaluate whether AGENCIA, a brief psychological program supported by digital technology and artificial intelligence, can help reduce emotional and behavioral difficulties in adolescents aged 12 to 18. These difficulties may include irritability, impulsive behaviors, conflicts at home or at school, or difficulties in managing intense emotions. The study also aims to determine whether the effects are similar across adolescents with different symptom profiles or neurodevelopmental characteristics.\n\nParticipants will be randomly assigned to one of three groups:\n\nAGENCIA Digital: a self-guided online version completed at home. AGENCIA in-person with a digital assistant: a clinician-delivered version supported by an interactive digital assistant to guide the exercises.\n\nDigital psychoeducation (control): a self-guided online program providing general information about adolescent well-being.\n\nThe main research questions are:\n\nDoes AGENCIA reduce overall emotional and behavioral difficulties? Does the program improve functioning, family accommodation, and personal agency (a young person's sense of being able to act and make changes)? Are the effects similar across adolescents with different profiles or neurodevelopmental characteristics?\n\nParticipants will:\n\n* Complete three structured sessions depending on their assigned group.\n* Complete brief online questionnaires at baseline (T0), immediately after the sessions (T1), and at 1-month (T2) and 6-month (T3) follow-ups.\n* Receive brief phone calls during follow-ups to support questionnaire completion.\n\nA total of 465 adolescents will take part in the study. Participation is voluntary and does not replace usual clinical care. The study does not involve medication or invasive procedures, and all digital tools operate within secure institutional systems.",[25,153,154,155,156,157],"Neurodevelopmental Disorders","Impulsivity","Emotional Dysregulation","Distress, Emotional","Distress, Psychological",[159,160,161,162,163,164,165,166],"Adolescents","Randomized controlled trial","Personal Agency","Digital health intervention","Neurodevelopmental disorders","Family accommodation","Conversational AI","Trans diagnostic interventions","2026-04-23",{"date":169,"type":43},"2026-04-30",{"date":171,"type":21},"2026-04-01",{"date":173,"type":21},"2028-12-31",{"name":175,"class":176},"Fundación Pública Andaluza para la gestión de la Investigación en Sevilla","OTHER",{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":183,"eligibilityCriteria":184,"healthyVolunteers":120,"sex":185,"minAge":147,"maxAge":186,"enrollmentInfo":187,"targetDuration":4,"studyType":97,"phases":188,"briefSummary":190,"conditions":191,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":138},"100634844","phase-4-teen-vulnerability-to-irritability-brain-and-estrogen-changes-100634844","NCT07544966","Teen Vulnerability to Irritability: Brain and Estrogen Changes","Neurobiological Mechanisms of Susceptibility to Estradiol Fluctuation in Female Adolescents at Risk of Suicide: An Experimental Approach.","TeenVIBE","Inclusion Criteria:\n\n* Assigned female sex at birth\n* Between the ages of 12 and 16\n* Be eligible to receive a low-dose oral contraceptive (COC)\n* Post-menarche. Participants will be post-menarche to avoid potential OC-related effects on bone growth prior to menarche\n* At risk of suicide. To be considered \"at suicide risk\" participants must meet the following-Mood and Feelings Questionnaire score of ≥ 27\n\nExclusion Criteria:\n\n* Personal history of metabolic or autoimmune disease\n* Epilepsy\n* Endometriosis\n* Cardiovascular, gastrointestinal, hepatic, renal, or pulmonary disease Diabetes mellitus with vascular disease\n* Uncontrolled hypertension\n* Liver tumors (benign or malignant) or liver disease\n* Undiagnosed abnormal uterine bleeding\n* Headaches with focal neurological symptoms or migraine with aura\n* Known or suspected pregnancy\n* Current or past deep vein thrombosis or pulmonary embolism\n* Cerebrovascular disease Coronary artery disease\n* Thrombogenic valvular or rhythm disease (e.g., subacute bacterial endocarditis with valvular disease, atrial fibrillation)\n* Inherited or acquired hypercoagulopathies\n* Current or history of breast cancer or other hormone-sensitive malignancy\n* Use of Hepatitis C drug combinations containing ombitasvir\u002Fparitaprevir\u002Fritonavir, with or without dasabuvir\n* Personal or first-degree relative with breast cancer or thromboembolic events","FEMALE","16 Years",{"count":96,"type":21},[189],"PHASE4","Purpose: Risk of severe psychopathology increases dramatically during adolescence, especially for females. Changes in ovarian steroids across the menstrual cycle produce windows of vulnerability to mood disturbances, particularly during the abrupt withdrawal of estradiol (E2) and progesterone (P4) prior to menses onset. Irrefutable evidence links stress with affective symptoms, potentially mediated by E2-related modifications of frontolimbic connectivity and prefrontal gamma-aminobutyric acid (GABA) inhibitory signaling. The primary objective of this project is to empirically test the impact of E2 and P4 change on vulnerable brain networks associated with irritability and other depressive symptoms in female adolescents at risk of suicide.\n\nParticipants: The investigators will enroll 50 female adolescents ages 12-16 who are at risk of suicide (i.e., moderate depressive symptoms), and are eligible to receive oral contraceptives and undergo MRI imaging.\n\nProcedure: Using a randomized, placebo-controlled, cross-over design, participants will be studied under two conditions: 8 weeks of E2 and P4 stabilization (continuous combined oral contraceptive (COC) to prevent perimenstrual withdrawal) and 8 weeks of placebo, with a 1-month washout after each condition. Each condition will include: 1) daily samples of E2 and P4 urinary metabolites, 2) daily symptom ratings(e.g., irritability, negative affect and suicidal thoughts and behaviors (STBs)), and 3) a neuroimaging session with MRI and magnetic resonance spectroscopy (MRS).",[192,25],"Depression - Major Depressive Disorder","2026-04-15",{"date":195,"type":43},"2026-04-22",{"date":197,"type":21},"2026-06-01",{"date":199,"type":21},"2029-04",{"name":201,"class":176},"University of North Carolina, Chapel Hill",{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":4,"eligibilityCriteria":208,"healthyVolunteers":11,"sex":16,"minAge":209,"maxAge":147,"enrollmentInfo":210,"targetDuration":4,"studyType":97,"phases":212,"briefSummary":213,"conditions":214,"keywords":217,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":51},"100583066","phase-4-predictors-of-improvements-in-irritability-and-aggression-in-children-with-adhd-treated-with-cns-stimulants-100583066","NCT06871488","Predictors of Improvements in Irritability and Aggression in Children With ADHD Treated With CNS Stimulants","Identification of Neural Markers of Aggression and Irritability and Their Capacity to Predict Treatment Response to CNS Stimulant Medication in Youth With ADHD","Inclusion Criteria:\n\n1. Meet criteria for any presentation of ADHD\n2. Moderate or worse impairment related to ADHD\n3. Elevated levels of irritability and\u002For aggression on guardian ratings of Affective Reactivity Index and Retrospective Modified Overt Aggression Scale\n4. fluent in English for child and guardian\n5. Guardian and child are willing to have child take CNS stimulant medication for ADHD\n\nExclusion Criteria:\n\n1. Medical contraindications to use of CNS stimulants\n2. Autism Spectrum Disorder,\n3. Bipolar Disorder,\n4. Intellectual\u002FDevelopmental Delay\n5. current use of antipsychotic, mood stabilizing\n6. Use of other medications that impact EEG data collection (e.g. benzodiazepenes)\n7. hearing or visual deficits that impede ability to do computer tasks\n8. Current Major Depressive Episode\n9. Current suicidal ideation\n10. child has failed two fully optimized trials of methylphenidate products AND two for amphetamine products","7 Years",{"count":211,"type":21},136,[189],"Impulsive Aggression and chronic irritability (IACI) often occur together and are one of the most common reasons children present for behavioral health (BH) care. ADHD frequently associated with IACI as upwards of 50% of youth with ADHD manifest impairing IACI levels. IACI is the most common reason that children with ADHD are prescribed antipsychotics and admitted to inpatient BH units. Systematic dose optimization of CNS stimulants improves levels of IACI, reducing the need for these more intensive and burdensome treatments. However, response varies, with over half of children with ADHD showing meaningful improvement, upwards of 40% receiving minimal benefit and 3 to 10% exhibiting increased IACI levels. Symptom levels of ADHD or IACI and other demographic variables are of limited utility for predicting response, suggesting the need to move beyond symptoms in the search for treatment predictors. Youth with ADHD and IACI struggle with multiple aspects reinforcement learning (RL), defined as learning from interactions with the environment to reach a goal. Successful RL efforts tap multiple cognitive functions. In controlled laboratory tasks, youth with IACI and various BH disorders exhibit excessive behavioral and neural response to receiving reward (reward responsiveness), difficulty processing environmental cues to adapt behavior to meet a goal (set shifting\u002Fgoal updating) and impaired ability to flexibly attend to relevant stimuli when blocked from a goal (frustrative nonreward). Event related potentials (ERP) are small electrical responses in the brain in response to specific events or stimuli measured by electroencephalogram (EEG) testing. ERPs exist that can serve as established neural measures of each of these cognitive functions offering a child friendly means to assess their contribution to observable levels of IACI.\n\nCNS stimulants improve functioning in these specific realms and impact associated ERPs to the degree that differences between ADHD and non-ADHD youth disappear. This study will examine the capacity of these ERPs to predict levels of IACI exhibited by children with ADHD when at home. Investigators will then assess if variability across children in the capacity of CNS stimulants to impact RL associated ERPs accounts for differences in the clinical effects of CNS stimulant medications to improve IACI at home using a multimethod battery integrating ERPs, parent report and task performance. Specifically, investigators will examine variance in the reward positivity (RewP) ERP when receiving reward feedback, the switch positivity (SwP) ERP measuring mental effort when cued to shift set and the change in P3b amplitude measuring attention allocation when transitioning from reward to nonreward on a go-no-go task. To achieve these aims, 136 children with ADHD and elevated IACI levels will have their CNS stimulant dose optimized over six weeks and then complete a two week within subjects crossover trial of placebo versus optimal dose. ERP collection will be completed within each blinded week. Parent ratings will be gathered 3 times per day including during peak and off-peak times of medication efficacy to capture the variance in IACI levels within the day and disentangle reports of worsening IACI related to loss of previously beneficial medication effects versus those most likely related to a direct adverse response to medication.",[215,25,216],"ADHD - Attention Deficit Disorder With Hyperactivity","Aggression Childhood",[218,219,25,220],"ADHD","CNS Stimulants","Aggression",{"date":222,"type":43},"2026-04-20",{"date":224,"type":43},"2026-03-05",{"date":226,"type":21},"2030-06-30",{"name":228,"class":176},"Milton S. Hershey Medical Center",{"id":230,"slug":231,"hasResults":11,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":4,"eligibilityCriteria":235,"healthyVolunteers":11,"sex":16,"minAge":236,"maxAge":147,"enrollmentInfo":237,"targetDuration":4,"studyType":97,"phases":239,"briefSummary":240,"conditions":241,"keywords":246,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":51},"100629020","behavioral-parent-training-with-and-without-ai-support-for-children-with-disruptive-behaviors-100629020","NCT07469215","Behavioral Parent Training With and Without AI Support for Children With Disruptive Behaviors","A Pilot Randomized Controlled Trial of Behavioral Parent Training (BPT) With or Without AI Support in Children With Disruptive Behaviors","Inclusion Criteria:\n\n* Being a primary caregiver with a child aged 5 to 12 years exhibiting disruptive behaviors (e.g., symptoms of ODD, CD, IED, ADHD, and\u002For unspecified behavioral problems).\n* Having access to an electronic device and regular internet access.\n* Stable concomitant intervention including medications throughout the study.\n* Speak Spanish or Catalan language.\n* Signed informed consent by parents or legal guardians of the child.\n\nExclusion Criteria:\n\n* Having ASD as primary diagnosis.\n* Psychosis, self-harming behaviors, severe mood disorder.\n* Known Intelligent quotient \\\u003C 70\n* Caregivers and\u002For children receiving any concurrent psychological treatment.\n* No signing the informant consent.","5 Years",{"count":238,"type":21},40,[99],"The goal of this clinical trial is to learn if adding an artificial intelligence (AI) application called to standard Behavioral Parent Training (BPT) helps families with children who have disruptive behavior problems. It will also help researchers understand if the app is easy to use and helpful for parents.\n\nThe main question it aims to answer is:\n\n\\- Is it feasible and acceptable for parents to use the AI app alongside their therapy sessions?\n\nThe secondary questions it aims to answer are:\n\n* Does the app help reduce children's disruptive behaviors and irritability more than therapy alone?\n* Does using the app help lower stress, anxiety, and depression levels for the parents?\n\nResearchers will compare:\n\n1. Standard BPT: Parents receive 8 weekly group training sessions (online).\n2. BPT plus ParenteAI: Parents receive the same 8 weekly sessions plus 24\u002F7 access to an AI virtual assistant for personalized support.\n\nParticipants will:\n\n* Attend 8 weekly group training sessions.\n* Complete surveys about their child's behavior and their own well-being at baseline, after group training sessions 4 and 8, and 3 and 6 months after finalizing the group training.\n* If in the experimental group, use the ParenteAI app to get real-time coaching and support for managing their child's behavior at home.\n* Provide feedback on their experience and satisfaction with the program.",[242,30,243,244,25,245],"Behavior Problem of Childhood and Adolescence","Artificial Intelligence (AI)","Disruptive Behaviours","Attention Deficit Disorder With Hyperactivity (ADHD)",[247,30,248,25,249,250],"Disruptive behaviors","Artifical intelligence","Behavior problems","Attention Deficit Disorder with Hyperactivity (ADHD)","2026-03-09",{"date":253,"type":43},"2026-03-13",{"date":255,"type":21},"2026-04",{"date":257,"type":21},"2027-03",{"name":259,"class":176},"Fundació Sant Joan de Déu",{"id":261,"slug":262,"hasResults":11,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":266,"eligibilityCriteria":267,"healthyVolunteers":120,"sex":16,"minAge":93,"maxAge":268,"enrollmentInfo":269,"targetDuration":4,"studyType":97,"phases":271,"briefSummary":272,"conditions":273,"keywords":275,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":51},"100625603","fluoxetine-on-emotional-experience-flex-study-100625603","NCT07424781","Fluoxetine on Emotional Experience (FLEX) Study","The Effect of Fluoxetine Treatment on Anger Processing in Healthy Young People","FLEX","Inclusion Criteria:\n\n* Be aged 18-24 years (inclusive)\n* Be resident in the UK for the duration of the study\n* Have normal or corrected to normal vision\n* Participant is willing and able to give informed consent for participation in the research\n* Sufficiently fluent English to understand and complete the study\n\nExclusion Criteria:\n\nThe participant may not enter the study if ANY of the following apply:\n\nPsychiatric History:\n\n* Current or past diagnosis of any psychiatric disorder, as determined by the Structured Clinical Interview for the DSM-5 (SCID-5) and self-report. This includes, but is not limited to, depression, anxiety disorders, alcohol or drug dependency, personality disorders, suicidal ideation, and other psychiatric conditions;\n* First degree relative with a diagnosis of mania;\n\nLifestyle:\n\n* Heavy smoker or vaper (\\> 10 cigarettes per day, or \\>2 mL e-liquid, or \\>15mg\u002Fday from a nicotine patch);\n* Heavy use of caffeine (drink \\> 4 of 250ml cups\u002Fcans of coffee or energy drinks per day);\n* Heavy drinker (drink \\>14 standard alcoholic drinks per week);\n* Current or recent use (in the last 3 months) of any psychoactive substance according to self-report and a urine drug test screening for recent use of 10 common recreational substances;\n\nPhysical Health:\n\n* Severely underweight or overweight in a manner that renders them unsuitable for the study in the opinion of the study medical advisor;\n* Known contraindication to fluoxetine, such as hypersensitivity to fluoxetine or any component in its formulation;\n* Pregnancy, as determined by a urine pregnancy test or plans to become pregnant within the next 3 months;\n* Breastfeeding;\n* Not able to consume gelatine;\n\nMedical History:\n\n* Past or ongoing health issue which, in the opinion of the study medical advisor, may interfere with the safety of the participant or the scientific integrity of the study, including but not limited to: seizures or epilepsy, heart rhythm problem, renal disease, hepatic disease, glaucoma, diabetes, bleeding disorders or clotting conditions (e.g., haemophilia, thrombocytopenia);\n* Diagnosis of a significant neurological condition (e.g., epilepsy, multiple sclerosis, traumatic brain injury).\n* Diagnosis of a neurodevelopmental condition, such as autism spectrum disorder (ASD) or attention-deficit\u002Fhyperactivity disorder (ADHD);\n* Current or recent use of medication that might interfere or interact with the effects of fluoxetine, in the opinion of the study medical advisor, including but not limited to: monoamine oxidase inhibitors (MAOIs), medications affecting serotonin levels (e.g., tramadol, triptans, St. John's Wort), anticoagulants or blood thinners (e.g., warfarin), anti-inflammatory medications (e.g., aspirin, ibuprofen), or medications known to affect heart rhythm;\n\nPrior Study Participation:\n\n* Participation in any other psychological or medical experiment involving taking any kind of drug\u002Fmedication\u002Fvaccine, within the last 3 months;\n* Participation in any other study involving the current or similar tasks, within the last 6 months;\n\nOthers\n\n•Any other significant finding which may arise during the screening process and which, in the opinion of the Principal Investigator\u002Fmedical advisor, may influence the scientific integrity of the study, or the participant's ability to participate in the study.","24 Years",{"count":270,"type":21},80,[99],"The goal of this clinical medicine study is to investigate how does antidepressant fluoxetine modulate anger processing in healthy young people . The main questions it aims is to answer are:\n\n1. How does fluoxetine affect responses to anger-related stimuli such as words, faces, and autobiographical recall?\n2. How does fluoxetine influence responses during frustration induction in frustrative non-reward and threat paradigms?\n3. Does the effect manifest in physiological markers, including heart rate variability and facial expressions?\n\nResearchers will compare fluoxetine to a placebo to see if drug fluoxetine affects anger processing.\n\nParticipants will:\n\nTake 20mg fluoxetine or a placebo every day for 7 days. Visit the university site for questionnaire and tasks assessments. Heart rate variability and facial expressions will be recorded in some of the tasks.",[192,25,274],"Depression",[276,277,278,279,280],"depression","young people","fluoxetine","irritability","anger","2026-02-18",{"date":283,"type":43},"2026-02-20",{"date":285,"type":43},"2025-10-01",{"date":287,"type":21},"2026-12-31",{"name":289,"class":176},"University of Oxford",{"id":291,"slug":292,"hasResults":11,"nctId":293,"briefTitle":294,"officialTitle":294,"acronym":4,"eligibilityCriteria":295,"healthyVolunteers":11,"sex":16,"minAge":296,"maxAge":93,"enrollmentInfo":297,"targetDuration":4,"studyType":97,"phases":299,"briefSummary":300,"conditions":301,"keywords":304,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":51},"100582946","implementation-of-the-pain-and-irritability-of-unknown-origin-piuo-pathway-in-community-pediatric-practices-100582946","NCT06869928","Implementation of the Pain and Irritability of Unknown Origin (PIUO) Pathway in Community Pediatric Practices","Pain Pathway Intervention Inclusion Criteria:\n\n* Children aged 6 months to 18 years with SNI (from any cause) with unexplained pain and irritability and whose cognitive or communication impairments prevent determination of pain location, cause, and type will be eligible to participate.\n* Eligible children will have cognitive impairment or be non-verbal. Parents should have sufficient English skills, or have access to assistance, to participate in the clinic visits and complete survey tools.\n\nPain Pathway Intervention Exclusion Criteria:\n\n* Children not within the specified age range\n* Children with communication capabilities and cognitive development to localize their pain\n* Children that have an explained and treatable cause of pain and irritability. Parents that do not have sufficient English skills, or have access to assistance, to participate in the clinic visits and complete survey tools.\n\nImplementation Participant Inclusion Criteria:\n\n* General pediatricians\n* Practicing in a community clinic in British Columbia\n\nImplementation Participant Exclusion Criteria:\n\n\\- Healthcare professionals who are not general pediatricians (e.g., pediatrician specialists, nurse practitioners, nurses, other allied health professionals)","6 Months",{"count":298,"type":21},20,[99],"The Pain and Irritability of Unknown Origin (PIUO) Pathway is a clinical pathway that was developed to evaluate and manage unexplained pain and irritability for children with severe neurological impairments (SNI) who cannot verbally communicate 'where it hurts'. The investigators studied the usefulness of the Pathway with families and expert clinicians in 4 centres across Canada. The aim of this Phase 2 study is to determine whether this tool can transfer from hospital research centres into the community. The Pathway will be used by community pediatricians across British Columbia (BC) when they see patients with PIUO. The investigators want to know how well these pediatricians can follow the Pathway. The goal is to create a systematic, cohesive approach to enhance the clinical care for all children with complex medical needs experiencing PIUO.",[302,25,303],"Pain","Neuropathic Pain",[302,25,305,306,303,307,308,309],"Pediatrics","Community","Severe Neurological Disabilities","Implementation Science","Patient Engagement","2025-03-05",{"date":312,"type":43},"2025-03-11",{"date":314,"type":43},"2024-06-28",{"date":316,"type":21},"2026-05",{"name":318,"class":176},"University of British Columbia",{"id":320,"slug":321,"hasResults":11,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":4,"eligibilityCriteria":325,"healthyVolunteers":11,"sex":16,"minAge":236,"maxAge":18,"enrollmentInfo":326,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":328,"conditions":329,"keywords":330,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":337,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":342,"locationsCount":51},"100578670","ap-metabolism-transcriptomics-100578670","NCT06814314","AP Metabolism Transcriptomics","Pilot Study of Transcriptomic Alterations Associated with Antipsychotic-induced Metabolic Disorders in Children and Adolescents","Inclusion Criteria:\n\n* age 5-17 years;\n* group 1: antipsychotic users with metabolic disorders;\n* group 2: antipsychotic users without metabolic disorders;\n* group 3: non-antipsychotic users with metabolic disorders. The definition of antipsychotic use includes daily use for at least 3 months prior to enrollment.\n\nThe definition of metabolic disorders includes: BMI-Z for age, sex and height \\> +1 Waist circumference \\> 90th percentile for age, sex and height Diastolic or systolic blood pressure \\> 90th percentile for age, sex and height Fasting blood glucose \\> 99 mg\u002Fdl Fasting triglycerides \\> 149 mg\u002Fdl Fasting cholesterol \\\u003C 41 mg\u002Fdl.\n\nPatients with metabolic disorders are defined as those who meet at least one of the above criteria.\n\nPatients without metabolic disorders are defined as those who do not present any of the above criteria.\n\nExclusion Criteria:\n\n* presence of diagnosed genetic conditions known to alter energy metabolism and\u002For nutrition;\n* presence of diagnosed eating disorders;\n* habitual use of supplements known to alter energy metabolism and\u002For nutrition;\n* concomitant use of drugs known to alter energy metabolism and\u002For nutrition.",{"count":327,"type":21},100,"It is known from the literature that treatment with antipsychotic drugs (AP) induces, even before changes in blood chemistry parameters, changes in gene transcription that are evident at the level of peripheral blood mononuclear cells.\n\nIn this pilot study we intend to evaluate the transcriptomic profile of children and adolescents who are undergoing treatment with antipsychotics and show metabolic disorders, in order to compare it to the profile of similar patients who do not use antipsychotics, but show metabolic disorders, or who use antipsychotics, but do not show metabolic disorders.\n\nThe hypothesis is that a different transcriptomic profile can be identified between the three populations under study, such as to allow to hypothesize that a series of transcripts can be used as early biomarkers of whether treatment with antipsychotics can induce metabolic disorders in the individual patient or not. This information could be used to improve the management of antipsychotic therapies in the direction of personalized medicine, reducing metabolic risks.",[153,25],[331,332,333,334,335],"antipsychotic drugs","dyslipidemia","pre-diabetes","obesity","transcriptomics","2025-02-03",{"date":338,"type":43},"2025-02-07",{"date":340,"type":43},"2023-04-30",{"date":316,"type":21},{"name":343,"class":176},"IRCCS Eugenio Medea"]