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

Forest Laboratories

Status and phase: Completed; Phase 2

Conditions: Bipolar Depression

Treatments: Drug: placebo; Drug: cariprazine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00852202

RGH-MD-52

Details and patient eligibility

About

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

Enrollment: 234 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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234 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

0.25 - 0.75 mg/day cariprazine capsules, oral administration, once daily dosing.

Treatment:

Drug: cariprazine

Drug: cariprazine

2

Experimental group

Description:

1.5 - 3.0 mg/day cariprazine capsules, oral administration, once daily dosing.

Treatment:

Drug: cariprazine

Drug: cariprazine

3

Placebo Comparator group

Description:

Matching placebo capsules, oral administration, once daily dosing.

Treatment:

Drug: placebo