Trials / Completed
CompletedNCT01058096
Safety and Efficacy of Cariprazine for Mania
A Double-Blind, Placebo-Controlled, Evaluation of the Safety and Efficacy of Cariprazine in Patients With Acute Mania Associated With Bipolar I Disorder
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 323 (actual)
- Sponsor
- Forest Laboratories · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cariprazine | Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine. |
| DRUG | Placebo | Patients who meet eligibility criteria will be administered a once daily oral dose of placebo. |
Timeline
- Start date
- 2010-02-01
- Primary completion
- 2011-07-01
- Completion
- 2011-07-01
- First posted
- 2010-01-28
- Last updated
- 2017-04-17
- Results posted
- 2017-04-17
Locations
28 sites across 2 countries: United States, India
Source: ClinicalTrials.gov record NCT01058096. Inclusion in this directory is not an endorsement.