Safety and Efficacy of Cariprazine for Bipolar I Disorder

Conditions

• Bipolar I Disorder
• Mania

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Cariprazine — DRUG
  Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for three weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
• Placebo — DRUG
  Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for three weeks.

Study Details

The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine monotherapy versus placebo for the treatment of acute manic or mixed episodes associated with bipolar I disorder.

Key Dates

Start date

Feb 28, 2010

Status verified

Mar 2017

Primary completion

Dec 31, 2011

Completion

Dec 31, 2011

Study Design

Enrollment

497 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cariprazine (3-6 mg/day)
  Cariprazine 3 milligrams (mg) - 6 mg capsules oral administration, once per day for 3 weeks.
• Experimental: Cariprazine (6-12 mg/day)
  Cariprazine 6 mg - 12 mg capsules oral administration, once per day for 3 weeks.
• Placebo Comparator: Placebo
  Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.

Primary Outcome Measure

Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Week 3 [ Time Frame: Baseline, Week 3 ]

Locations (23)

Find similar trials in Little Rock, AR

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