Phase 3
Completed N=497
Safety and Efficacy of Cariprazine for Bipolar I Disorder
Source: ClinicalTrials.gov NCT01058668 ↗Enrolled (actual)
497
Serious AEs
3.8%
Results posted
Apr 2017
Primary outcomePrimary: Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Week 3 — -12.5; -18.6; -18.5 score on a scale — p=<0.001
◆ Published Evidence
Highly cited
119citations · ~11 / year
Efficacy and safety of low- and high-dose cariprazine in acute and mixed mania associated with bipolar I disorder: a double-blind, placebo-controlled study.
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.
Linked Publications (3)
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Efficacy and safety of low- and high-dose cariprazine in acute and mixed mania associated with bipolar I disorder: a double-blind, placebo-controlled study.
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Clinically relevant response and remission outcomes in cariprazine-treated patients with bipolar I disorder.
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Cariprazine for the treatment of bipolar mania with mixed features: A post hoc pooled analysis of 3 trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Week 3 |
-12.5; -18.6; -18.5 | <0.001 sig |
| SECONDARY Change From Baseline in Clinical Global Impression-Severity (CGI-S) Total Score at Week 3 |
-1.3; -1.9; -1.9 | <0.001 sig |
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 (NCT01058668) and the linked publication. 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.