Phase 3
Completed N=403
Long-term Safety and Tolerability of Cariprazine for Bipolar I Disorder
Source: ClinicalTrials.gov NCT01059539 ↗Enrolled (actual)
403
Serious AEs
8.5%
Results posted
Jun 2019
Primary outcomePrimary: Change From Baseline in the YMRS Total Score at Week 16 — -15.2 Units on a scale
◆ Published Evidence
Established
36citations · ~5 / year
The safety and tolerability of cariprazine in patients with manic or mixed episodes associated with bipolar I disorder: A 16-week open-label study.
Summary
The objective of this study is to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with bipolar I disorder.
Linked Publications
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The safety and tolerability of cariprazine in patients with manic or mixed episodes associated with bipolar I disorder: A 16-week open-label study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the YMRS Total Score at Week 16 |
-15.2 | — |
| SECONDARY Change From Baseline in the MADRS Total Score at Week 16 |
-1.6 | — |
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).
- Patients who experienced a manic or mixed episode that required treatment within the past 12 months.
- Patients with normal physical examination, laboratory, vital signs, and electrocardiogram (ECG).
Exclusion Criteria
- Patients with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I disorder.
Data sourced from ClinicalTrials.gov (NCT01059539) 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.