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

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

Official Title
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A Double-blind, Placebo-controlled Study of RGH-188 (Cariprazine) in Bipolar Depression

Conditions
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Bipolar Depression

Intervention / Treatment
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* Drug: cariprazine
* Drug: cariprazine
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>0.25 - 0.75 mg/day cariprazine capsules, oral administration, once daily dosing. | Drug: cariprazine<br>* Drug: cariprazine (0.25 - 0.75 mg/day)<br>|
| Experimental: 2<br>1.5 - 3.0 mg/day cariprazine capsules, oral administration, once daily dosing. | Drug: cariprazine<br>* Drug: cariprazine (1.5 - 3.0 mg/day)<br>|
| Placebo Comparator: 3<br>Matching placebo capsules, oral administration, once daily dosing. | Drug: placebo<br>* placebo capsules, oral administration, once daily dosing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to Week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bipolar, depression