NCT01058668

Safety and Efficacy of Cariprazine for Bipolar I Disorder

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: 497 (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

• Mania
• Bipolar I Disorder

Interventions

Type	Name	Description
DRUG	Cariprazine	Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for three weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
DRUG	Placebo	Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for three weeks.

Timeline

• Start date: 2010-02-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2010-01-29
• Last updated: 2017-04-12
• Results posted: 2017-04-12

Locations

66 sites across 6 countries: United States, Croatia, Romania, Russia, Serbia, Ukraine