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.

Conditions

• Bipolar I Disorder
• Depression

Eligibility Criteria

Sex

ALL

Age

10 Years - 17 Years

Healthy Volunteers

Not accepted

Interventions

• Cariprazine — DRUG
  Oral Capsule
• Placebo — DRUG
  Oral Capsule

Study Details

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.

Key Dates

Start date

Apr 28, 2021

Status verified

Jun 2026

Primary completion

Mar 31, 2027

Completion

Mar 31, 2027

Study Design

Enrollment

380 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cariprazine
  Participants will receive flexible dose Cariprazine over a 6 week treatment period.
• Placebo Comparator: Placebo
  Participants will receive Placebo over a 6 week treatment period.

Primary Outcome Measure

Number of Participants with Adverse Events [ Time Frame: Baseline (Week 0) to Week 10 ]

Central Contacts

• ABBVIE CALL CENTER
  844-663-3742
  [email protected]

Locations (69)

Find similar trials in Bentonville, AR

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