Phase 3
N=312
Safety and Efficacy of Cariprazine for Mania
Bipolar Disorder · Mania
Bottom Line
View on ClinicalTrials.gov: NCT01058096 ↗Enrolled (actual)
312
Serious AEs
3.5%
Results posted
Apr 2017
Primary outcome: Primary: Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Week 3 — -15.3; -19.6 score on a scale — p=0.0004
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Cariprazine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Forest Laboratories
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Week 3 |
-15.3; -19.6 | 0.0004 sig |
| SECONDARY Change From Baseline in Clinical Global Impression-Severity (CGI-S) Total Score at Week 3 |
-1.3; -1.6 | 0.0027 sig |
Summary
The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine monotherapy versus placebo for the treatment of acute manic or mixed episodes associated with bipolar I disorder.
Eligibility Criteria
Inclusion Criteria
- Patients who have provided informed consent prior to any study specific procedures
- Patients 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 for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID) manic or mixed type with or without psychotic symptoms
- Voluntarily hospitalized for current manic episode
- Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG)
Exclusion Criteria
- Patients 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 six months
Data sourced from ClinicalTrials.gov (NCT01058096). 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.