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, called treatment arms. There is a 1 in 2 chance that a participant will be assigned to placebo. Around 380 Participants ages 10-17 years with bipolar I disorder will be enrolled in approximately 60 sites worldwide. Participants receiving the study drug will receive Dose A or B of Cariprazine based on age and weight. At Week 3, participants with insufficient response will have their dose increased to Dose B or Dose C, while participants with sufficient response will continue receiving the Dose A or B for the remainder of the treatment period. The treatment period will be followed by a safety follow-up (SFU) period for 4 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular weekly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
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Number of Participants with Adverse Events
Timeframe: Baseline (Week 0) to Week 10
Abnormal Change from Baseline in Vital Signs
Timeframe: Baseline (Week 0) to Week 10
Number of Participants with Incidence of Abnormal Clinical Laboratory Test Results
Timeframe: Baseline (Week 0) to Week 6
Change in Electrocardiogram (ECG)
Timeframe: Baseline (Week 0) to Week 6
Change From Baseline in Simpson-Angus Scale (SAS)
Timeframe: Baseline (Week 0) to Week 6
Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)
Timeframe: Baseline (Week 0) to Week 10
Change From Baseline in Barnes Akathisia Rating Scale (BARS)
Timeframe: Baseline (Week 0) to Week 6
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)
Timeframe: Baseline (Week 0) to Week 6
Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score
Timeframe: Baseline (Week 0) to Week 6