Phase 2 N=34 Characterization and Sequential Pharmacotherapy of Severe Mood Dysregulation
Severe Mood Dysregulation
Primary: Clinical Global Impression-Severity-Severe Mood Dysregulation — 4.91; 3.62; 4.30; 4.42 units on a scale — p=.58
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 2 N=53 A Controlled Trial of Serotonin Reuptake Inhibitors Added to Stimulant Medication in Youth With Severe Mood Dysregulation
Mood Disorder · Mental Disorder Diagnosed in Childhood · Attention Deficit and Disruptive Behavior Disorder
Primary: Percentage of Participants That "Much Improved" (Score of 2) in, or "Completely Recovered" (Score of 1) From Their Irritability Severity, as Measured With the Clinical…
Phase 4 N=24 Treatment With Quetiapine for Youth With Substance Use Disorders and Severe Mood Dysregulation
Substance Use Disorders · Bipolar Disorder · Mood Disorders
Primary: Change in Timeline Followback of Substance Use (TLFB) — 2.3; 3.3 Days
Phase 2 N=58 Oxytocin on Irritability/Emotional Dysregulation of Disruptive Behavior and Mood Disorders
Mood Disorder · Disruptive Behavior Disorders
Primary: Change in Affective Reactivity Index - Youth (ARI-Y) — -2.9; -0.8 score on a scale
N/A N=93 Preschooler Emotion Regulation in the Context of Maternal Borderline Personality Disorder
Borderline Personality Disorder · Emotional Problem
Primary: Maternal Emotion Dysregulation — 82.35; 91.8 score on a scale — p=.002
N/A N=60 Brain Emotion Circuitry-Targeted Self-Monitoring and Regulation Therapy (BE-SMART)
Mood Disorders
Primary: Functional Magnetic Resonance Imaging (fMRI) Blood Oxygen-level Dependent (BOLD) Signal Changes in Left Amygdala at Baseline and at the End of the Intervention — 1.62…
N/A N=22 Treatment of Aggression, Anger and Emotional Dysregulation in Borderline Personality Disorder
Borderline Personality Disorder
Primary: Self-Report of Difficulties in Emotion Regulation (DERS) — 101.5; 54.8; 120.5; 56.6 units on a scale — p=<0.004
N/A N=91 Mobile-enhanced Group CBT for Adolescents at Risk Severe Mood Disorders
Adolescents · Mood Disorders
Primary: Treatment Skill Practice — 16.1; 56.2; 44.3 treatment skill practices
Phase 4 N=40 Open-Label Study of N-Acetylcysteine in Children and Adolescents 5-17 With Bipolar Spectrum Disorders
Bipolar Disorder
Primary: Mean Change in the Young Mania Rating Scale (YMRS) Score — -8.1 score on a scale
Phase 4 N=20 Iloperidone Augmentation of SSRIs for Patients With Major Depressive Disorder With Residual Anger and Irritability
Major Depressive Disorder
Primary: SQ Anger/Hostility Scale — 4.8; 8; 6.7; 7.5 Score on Anger/Hostility Scale
Phase 3 N=350 Lurasidone Pediatric Bipolar Study
Bipolar I Depression
Primary: Change in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score as Compared to Placebo From Double-Blind Baseline to Week 6 (Day 43) Baseline — 59.2…
N/A N=7 Early Detection and Prevention of Mood Disorders in Children of Parents With Bipolar Disorder
Bipolar Disorder · Depression
Primary: K SADS-Present Version (KSADS-P) — 0; 2; 1; 0 participants
Phase 3 N=48 Major Depressive Disorder With Mixed Features - Extension
Major Depressive Disorder
Primary: Percentage of Subjects With Treatment Emergent Adverse Events (TEAEs) — 66.7 percentage of subjects
Phase 4 N=41 Iloperidone in Mixed States of Bipolar Disorder
Bipolar Disorder
Primary: Measure of Response by Change From Baseline to End of Study in BISS Depression and Mania Scale Scores — 35.7; 61.8; 25; 48 percentage change in score on BISS scale…
N/A N=28 Neurobehavioral Intervention as a Novel Treatment Approach for Emotion-Regulatory Deficits
Anxiety · Depression
Primary: Reaction Time to Facial Affect Identification During Emotional Conflict — 802.15; 889.14; 848.79; 937.97 milliseconds — p=0.004
Phase 3 N=283 A 6-Month Extension Study To The B2061032 Study To Evaluate The Safety, Tolerability, And Efficacy Of DVS SR In The Treatment Of Child And Adolescent Outpatients With MDD
Major Depressive Disorder
Primary: Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) — 78.0; 73.1; 71.1 Percentage of participants
N/A N=39 Transcranial Magnetic Stimulation for Adolescent Depression
Major Depressive Disorder
Primary: Hamilton Depression Rating Scale — 9.38 score on a scale
Phase 4 N=54 Natural Treatments for the Management of Emotional Dysregulation in Youth With Non-verbal Learning Disability (NVLD) and/or Autism Spectrum Disorders (ASD)
Non-verbal Learning Disorder · Autism Spectrum Disorder · Autism
Primary: Mean Change in the Parent-Young Mania Rating Scale (P-YMRS) Score — 0.0; -2.6 Units on a Scale
Phase 3 N=269 A 6-Month Open-Label Extension Study to the B2061014 Study to Evaluate the Safety, Tolerability and Efficacy of DVS SR in the Treatment of Children and Adolescents With MDD
Major Depressive Disorder
Primary: Percentage of Participants Experiencing a Treatment Emergent Adverse Event — 70.1; 75.3; 73.9; 73.1 Percentage of Participants
Phase 3 N=363 A Study Of DVS SR In Treatment Of Children And Adolescent Outpatients With MDD
Major Depressive Disorder
Primary: Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score (n=102, 104, 106) — -22.85; -23.70; -24.37 Score on a scale…
Phase 3 N=46 Placebo Controlled Trial of Valproate and Risperidone in Young Children With Bipolar Disorders
Bipolar Disorder
Primary: YMRS — 10; 18.82; 4.29 score on a scale
Phase 3 N=211 Major Depressive Disorder (MDD) With Mixed Features - Flexible Dose
Major Depressive Disorder With Mixed Features
Primary: Mean Change From Baseline to the 6-week Study Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Scores — -20.5; -13.0 units on a scale — p=<0.0001
Phase 2 N=48 Lamotrigine Monotherapy in Pediatric Bipolar Disorder
Bipolar Disorder
Primary: Young Mania Rating Scale (YMRS), — 19.61; 7.06; 5.68 units on a scale
Phase 4 N=27 A Clinical Trial Via Telepsychiatry of Treatments for the Management of Emotional Dysregulation in Youth
Mood Disturbance · Mood Disorders · Natural Supplements
Primary: Mean Change in the Parent-Young Mania Rating Scale (P-YMRS) Score — -2.4; -1.9 Units on YMRS Scale
N/A N=68 Group-Based Behavioral Therapy Combined With Stimulant Medication for Treating Children With Attention Deficit Hyperactivity Disorder and Impaired Mood
Attention Deficit Disorder With Hyperactivity
Primary: Mood Severity Index Measures Severity of Mood Symptoms (MSI).Range of 0-116; Clinicians Give to Parents and Child to Get Composite Score; Higher Scores=Greater Severity…
Phase 4 N=168 Treatment of Severe Childhood Aggression (The TOSCA Study)
Attention Deficit Disorder With Hyperactivity
Primary: NCBRF-TIQ D-Total Score — 43.5; 42.1; 24.9; 25.9 units on a scale
N/A N=65 Reducing Suicide Risk in Adolescents and Young Adults Via a Psychobehavioral Intervention to Regularize Daily Rhythms
Bipolar Disorder · Major Depressive Disorder · Mood Disorders
Primary: Mean Score Measuring Suicidal Ideation/Propensity (SI/P) Using Concise Health Risk Tracking Scale-Self Reported (CHRT-SR) to Assess for Propensity — 12.83; 12.41; 10.84…
N/A N=77 Role of Slow-wave Activity and Plasticity in MDD
Depression
Primary: Compare Indices of Net Synaptic Strength (Transcranial Magnetic Stimulation Evoked Potentials) in Individuals With MDD to Healthy Controls — 195.07; 179.16; 323.22…
Phase 2 N=143 SPD489 in Adults With Persistent Executive Function Impairments (EFI) and Partial or Full Remission of Recurrent Major Depressive Disorder
Major Depressive Disorder
Primary: Change From Baseline in Behavior Rating Inventory of Executive Function - Adult Version Global Executive Composite T-score (BRIEF-A GEC T) at Week 9, Last Observation…
N/A N=15 The S.M.A.R.T. Project: Stress Management and Resilience Training for Teens
Depression Mild · Resilience, Psychological · Adolescent Behavior
Primary: Time to Incident Depression — 36; 18.86 weeks — p=0.02