Long-term Safety and Tolerability of Cariprazine for Bipolar I Disorder

Conditions

• Bipolar I Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Cariprazine — DRUG
  Cariprazine was supplied in capsules.

Study Details

The objective of this study is to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with bipolar I disorder.

Key Dates

Start date

Feb 28, 2010

Status verified

May 2019

Primary completion

Feb 29, 2012

Completion

Feb 29, 2012

Study Design

Enrollment

403 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Cariprazine 3-12 mg/day for 16 weeks
  Participants received cariprazine 1.5 mg orally on Day 1 and cariprazine 3.0 mg orally on Days 2 and 3. Starting on Day 4, the dose could be increased in increments of 3 mg every 2 days up to a maximum dose of 12 mg, if the response was not adequate and there were no tolerability issues based on the judgment of the principal investigator.

Primary Outcome Measure

Change From Baseline in the YMRS Total Score at Week 16 [ Time Frame: Baseline to Week 16 ]

Locations (24)

Find similar trials in Springdale, AR

Related Studies

• 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.
  PHASE3 · Recruiting · AbbVie · Bentonville, Arkansas
• Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects
  PHASE3 · Enrolling By Invitation · Alkermes, Inc. · Dothan, Alabama
• Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder
  PHASE3 · Recruiting · Alkermes, Inc. · Dothan, Alabama
• Children's Bipolar Network Treatment Trial I
  Recruiting · University of California, Los Angeles · Los Angeles, California