Study on the Efficacy, Safety, and Tolerability of Cariprazine Relative to Placebo in Participants With Bipolar I Depression

Conditions

• Bipolar Disorder
• Depression

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Cariprazine — DRUG
• Placebo — DRUG

Study Details

This study investigates the efficacy of a fixed-dose regimen of cariprazine 1.5 milligram (mg)/day or 3 mg/day compared to placebo for treatment of the depressive episode in participants with bipolar I disorder. The safety and tolerability of the fixed-dose regimens will be evaluated.

Key Dates

Start date

Mar 17, 2016

Status verified

Jan 2019

Primary completion

Jul 19, 2017

Completion

Jul 19, 2017

Study Design

Enrollment

488 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo
  Following a 7 to 14 days screening/washout period, placebo-matching cariprazine capsule, one per day, orally for 6 weeks.
• Experimental: Cariprazine 1.5 mg
  Following a 7 to 14 days screening/washout period, cariprazine 1.5 milligram (mg) capsule, one per day, orally for 6 weeks.
• Experimental: Cariprazine 3.0 mg
  Following a 7 to 14 days screening/washout period, cariprazine 1.5 mg capsule, one per day for 2 weeks followed by cariprazine 3.0 milligram (mg) capsule, one per day, orally beginning on Day 15 for 4 weeks.

Primary Outcome Measure

Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Score at Week 6 [ Time Frame: Baseline (Week 0) to Week 6 ]

Locations (44)

Find similar trials in Little Rock, AR

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