Phase 2
Completed N=584
Safety, Tolerability, and Efficacy of Cariprazine in Participants With Bipolar Depression
Depression, Bipolar
Source: ClinicalTrials.gov NCT01396447 ↗
Enrolled (actual)
584
Serious AEs
1.7%
Results posted
May 2018
Primary outcomePrimary: Change From Baseline in the Montgomery-Åsberg Depression Rating Scale Total Score at Week 6 — -11.1; -13.0; -15.1; -13.7 units on a scale — p=0.1292
Summary
The objective of this study was to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of participants with bipolar depression.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Montgomery-Åsberg Depression Rating Scale Total Score at Week 6 |
-11.1; -13.0; -15.1; -13.7 | 0.1292 |
| SECONDARY Change From Baseline in the Clinical Global Impressions-Severity Total Score at Week 6 |
-1.0; -1.1; -1.4; -1.3 | 0.3025 |
Eligibility Criteria
Inclusion Criteria
- Participants who have provided informed consent prior to any study specific procedures.
- Participants currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder as confirmed by the Structured Clinical Interview (SCID) with a current with a current major depressive episode of at least 4 weeks and not exceeding 12 months in duration.
- Participants with normal physical examination, laboratory, vital signs, and/or echocardiogram (ECG).
- Verified previous manic or mixed episode.
- Participants with a total Hamilton Rating Scale for Depression (HAMD)-17 score ≥ 20.
- Participants with a HAMD-17 item 1 score ≥ 2.
- Participants with a Clinical Global Impression of Severity (CGI-S) score ≥ 4.
Exclusion Criteria
- Participants with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I disorder that was the primary focus of treatment within the previous 6 months.
- Women who are pregnant or breast feeding
- Participants with Young Mania Rating Scale (YMRS) total score > 10
- Participants who have dementia, mental retardation, schizophrenia/schizoaffective disorder.
Data sourced from ClinicalTrials.gov (NCT01396447). 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.