Safety and Efficacy of RGH-188 (Cariprazine) in Bipolar Depression

Forest Laboratories234 enrolled

Overview

The purpose of this study is to evaluate the efficacy, safety, and tolerability of cariprazine in the treatment of outpatients with bipolar depression.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

234

Conditions

Bipolar Depression

Interventions

cariprazineDRUG

Drug: cariprazine (0.25 - 0.75 mg/day)

cariprazineDRUG

Drug: cariprazine (1.5 - 3.0 mg/day)

placeboDRUG

placebo capsules, oral administration, once daily dosing

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Men and women, 18-65 years old * Currently meet the DSM-IV-TR criteria for Bipolar I or II Disorder without psychotic features, with a current depressive episode * A verified previous manic, hypomanic, or mixed episode * Score of 20 or higher on the HAMD-17 * Score of 2 or higher on Item 1 of the HAMD Exclusion Criteria: * Score greater than 12 on the Young Mania Rating Scale * Eight or more episodes of a mood disturbance (depression, mania, hypomania, or mixed state) within the 12 months prior to Visit 1 * Principal DSM-IV-TR-based diagnosis of an axis I disorder other than bipolar disorder (a secondary diagnosis of comorbid Generalized Anxiety Disorder, Social Anxiety Disorder, or specific phobias is acceptable)

Locations (26)

Outcomes

Primary Outcomes

Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)

The patient is rated on a scale from 0-6 on 10 items. Apparent sadness, reported sadness, lassitude, pessimistic thoughts, inner tension, suicidal thoughts, reduced sleep and appetite, concentration difficulties, inability to feel. The overall MADRS score ranges from 0-60, with 0 meaning no symptoms and score of 60 meaning maximum severity.

Time frame: Baseline to Week 8

Secondary Outcomes

Change in Baseline in Clinical Global Impressions-Improvement ( CGI-I )

The patient was rated on a scale from 1 to 7, with 1 indicating the patient was very much improved and 7 indicating that the patient was very much worse.

Time frame: Baseline to Week 8

Data from ClinicalTrials.gov

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