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A Study to Assess Change in Disease Activity and Adverse Events (AEs) With Cariprazine in the Treatment of Depressive Episodes in Pediatric Participants Participants (10 to 17 Years of Age) With Bipolar I Disorder.

RecruitingPhase 3Ages 10 Years - 17 YearsAllAbbVie
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In plain words

What the trial is, and whether it could suit you

Bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult population and 1.8% of the pediatric population in the United States. The treatment of the depressive episodes of bipolar disorder in the pediatric population has not been as widely studied as the treatment of depressive episodes in bipolar disorder in adults, therefore pharmacotherapeutic options are limited. Given the change in disease state and safety demonstrated in adults with depressive episodes associated with bipolar I disorder, the purpose of this study is to evaluate the change in disease state and safety of cariprazine in the treatment of depressive episodes associated with bipolar I disorder in the pediatric population. Cariprazine is an approved drug for the treatment of depressive episodes in adult participants with bipolar I disorder. Study doctors put participants in 1 of 2 groups, call

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Participants with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) primary diagnosis of bipolar I disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL). * Current depressive episode is more than 2 weeks and less than 12 months in duration. * Participant has a lifetime history of at least one manic episode. * Children's Depression Rating Scale - Revised (CDRS-R) score \> = 45 at Visit 1 and Visit 2. * Young-Mania Rating Scale (YMRS) score \< = 12 with YMRS Item 1 (elevated mood) score \< = 2 at Visit 1 and Visit 2. * Clinical Global Impression-Severity (CGI-S) scale score of \> = 4 (moderately ill) at Visit 1 and Visit 2. Exclusion Criteria: * Participants with DSM-5 diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, psychotic disorder due to another medical condition, PTSD, antisocial personality disorder, or borderline personality disorder. * Participant has a history of meeting DSM-5 diagnosis for any substance-related disorder (except caffeine- and tobacco-related) within the 3 months before Screening Visit 1. * History of serotonin syndrome or neuroleptic malignant syndrome. * Four or more episodes of a mood disturbance within the 12 months before Visit 1. * DSM-5 diagnosis of intellectual disability (IQ \< 70), autism spectrum disorders, or documented history of chromosomal disorder with developmental impairment. * History of seizures, with the exception of febrile seizures. * Significant head trauma, history of tumor of the CNS, or any other condition that predisposes to seizures. * Participant requires concomitant treatment with moderate or strong CYP3A4 inhibitors or with any CYP3A4 inducers. * Participant requires concomitant treatment with any prohibited medication, supplement, or herbal product, including any psychotropic drug or any drug with psychotropic activity or with a potentially psychotropic component. * Use of a depot antipsychotic within 2 cycles of their respective dosing interval prior to Screening Visit 1. * Treatment with clozapine in a dose of \>= 50 mg/d in the past 2 years. * History of or any current ocular disease including, but not limited to, retinal detachment, intraocular surgery, laser treatment, glaucoma, cataracts, or clinically significant ocular trauma (with the exception of refractive errors).
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What it tests

  • Cariprazine
  • Placebo
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Where

81 sites
Pillar Clinical Research /ID# 226504
Bentonville, United States
Advanced Research Center /ID# 227073
Anaheim, United States
Care Access Research /ID# 226316
Beverly Hills, United States
Inland Pyschiatric Medical Group - Chino /ID# 278667
Chino, United States
ProScience Research Group /ID# 226223
Culver City, United States
National Institute of Clinical Research - Garden Grove /ID# 262835
Garden Grove, United States
Accellacare - Long Beach /ID# 279482
Long Beach, United States
Duplicate_Alliance for Research - Long Beach /ID# 226522
Long Beach, United States

โ€ฆand 73 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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