Phase 2
Completed N=227
Safety and Efficacy of RGH-188 (Cariprazine) in Bipolar Depression
Source: ClinicalTrials.gov NCT00852202 ↗Enrolled (actual)
227
Serious AEs
2.6%
Results posted
Aug 2018
Primary outcomePrimary: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) — 29.9; 30.2; 30.9 Score on scale — p=0.7408
Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of cariprazine in the treatment of outpatients with bipolar depression.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) |
29.9; 30.2; 30.9 | 0.7408 |
| SECONDARY Change in Baseline in Clinical Global Impressions-Improvement ( CGI-I ) |
2.1; 2.1; 2.1 | 0.3441 |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT00852202). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.