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.

Primary outcomes

1. Number of Participants with Adverse Events

   Time frame: Baseline (Week 0) to Week 10

   An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a casual relationship with this treatment. The investigator assesses the relationship of each event to the use of the study. A serious adverse event (SAE) is an event that results in death, is life threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event, that based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/ treatment emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of the study drug.

2. Abnormal Change from Baseline in Vital Signs

   Time frame: Baseline (Week 0) to Week 10

   Change in vital signs like systolic and diastolic blood pressure will be assessed.

3. Number of Participants with Incidence of Abnormal Clinical Laboratory Test Results

   Time frame: Baseline (Week 0) to Week 6

   Number of participants with incidence of abnormal clinical laboratory test results like hematology will be assessed.

4. Change in Electrocardiogram (ECG)

   Time frame: Baseline (Week 0) to Week 6

   12 -lead resting ECGs will be recorded. Parameters include RR interval, PR interval, QT interval, and QRS duration.

5. Change From Baseline in Simpson-Angus Scale (SAS)

   Time frame: Baseline (Week 0) to Week 6

   SAS is a 10-item rating scale for assessment of antipsychotic-induced parkinsonism in both clinical practice and research settings. Each item ranges from 0 (normal) to 4 (extreme symptoms). The scale consists of 1 item measuring gait (hypokinesia), 6 items measuring rigidity, and 3 items measuring glabella tap, tremor, and salivation, respectively.

6. Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)

   Time frame: Baseline (Week 0) to Week 10

   The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior, with a higher score denoting more severe suicidal ideation and behavior.

7. Change From Baseline in Barnes Akathisia Rating Scale (BARS)

   Time frame: Baseline (Week 0) to Week 6

   BARS is a 4-item rating scale used to assess drug-induced akathisia. The scale comprises items for rating the observable restless movements that characterize the condition, the subjective awareness of restlessness, and any distress associated with the akathisia (each on a 4-point scale from normal [0] to severe [3]). In addition, there is a global severity for akathisia rated on a 6-point scale (absent [0] to severe akathisia [5]).

8. Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)

   Time frame: Baseline (Week 0) to Week 6

   AIMS assesses abnormal involuntary movements, such as tardive dyskinesia, associated with antipsychotic drugs; it measures facial, oral, extremities, and trunk movements, as well as the participant's awareness of abnormal movements. The first 10 items are rated on a none (0) to severe (4) scale. There are an additional 2 items on dental status that are answered yes or no.

9. Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score

   Time frame: Baseline (Week 0) to Week 6

   The CDRS-R is a 17-item clinician-administered scale specifically developed for the assessment of depressive symptoms in children and adolescents. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. The CDRS-R will be administered by a clinician with extensive professional training in mental illness.