Safety, Tolerability, and Efficacy of Cariprazine in Participants With Bipolar Depression

Conditions

• Depression, Bipolar

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Placebo — DRUG
  Placebo was supplied in capsules.
• Cariprazine — DRUG
  Cariprazine was supplied in capsules.

Study Details

The objective of this study was to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of participants with bipolar depression.

Key Dates

Start date

Jul 26, 2011

Status verified

Mar 2018

Primary completion

Jan 10, 2014

Completion

Jan 10, 2014

Study Design

Enrollment

584 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo
  Participants received placebo orally once a day for 8 weeks.
• Experimental: Cariprazine 0.75 mg
  Participants received cariprazine 0.5 mg orally once on Days 1-2 and cariprazine 0.75 mg orally once a day starting on Day 3 for the remainder of the 8 week treatment period.
• Experimental: Cariprazine 1.5 mg
  Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, and cariprazine 1.5 mg orally once a day starting on Day 8 for the remainder of the 8 week treatment period.
• Experimental: Cariprazine 3.0 mg
  Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, cariprazine 1.5 mg orally on Days 8-14, and cariprazine 3.0 mg orally once a day starting on Day 15 for the remainder of the 8 week treatment period.

Primary Outcome Measure

Change From Baseline in the Montgomery-Åsberg Depression Rating Scale Total Score at Week 6 [ Time Frame: Baseline to Week 6 ]

Locations (38)

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