NCT00488618

Study Evaluating Cariprazine (RGH-188) in the Treatment of Patients With Acute Mania

A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of RGH-188 in Patients With Acute Mania Associated With Bipolar I Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 238 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a study designed to evaluate the efficacy, safety, and tolerability of RGH-188 monotherapy in the treatment of acute mania. This study will be 5 weeks in duration; 3 weeks double-blind treatment and 2-weeks safety follow-up. All patients meeting the eligibility criteria will be randomized to one of two treatment groups: RGH-188 or placebo

Conditions

• Bipolar Disorder

Interventions

Type	Name	Description
DRUG	Cariprazine (RGH-188)	Cariprazine 3 mg - 12 mg oral administration, once per day.
DRUG	Placebo	Dose-matched placebo oral administration, once per day.

Timeline

• Start date: 2007-06-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2007-06-20
• Last updated: 2017-04-14
• Results posted: 2017-04-14

Locations

1 site across 1 country: United States