Trials / Completed
CompletedNCT02670538
Study of the Efficacy of a Fixed-dose Regimen of Cariprazine Compared to Placebo for Treatment of the Depressive Episode in Participants With Bipolar I Disorder
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Fixed-Dose Clinical Trial Evaluating The Efficacy, Safety And Tolerability Of Cariprazine In Patients With Bipolar I Depression
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 493 (actual)
- Sponsor
- Forest Laboratories · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This study is designed to prospectively confirm the efficacy of a fixed-dose regimen of cariprazine 1.5 milligrams (mg)/day or 3 mg/day compared to placebo for treatment of the depressive episode in participants with bipolar I disorder. The safety and tolerability of the fixed-dose regimens will be evaluated.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cariprazine | Cariprazine capsule one per day orally. |
| DRUG | Placebo | Matching placebo capsule one per day orally. |
Timeline
- Start date
- 2016-03-31
- Primary completion
- 2018-01-18
- Completion
- 2018-01-18
- First posted
- 2016-02-01
- Last updated
- 2019-03-12
- Results posted
- 2019-02-05
Locations
89 sites across 8 countries: United States, Bulgaria, Croatia, Puerto Rico, Romania, Serbia, Slovakia, Ukraine
Source: ClinicalTrials.gov record NCT02670538. Inclusion in this directory is not an endorsement.