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

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00488618
• Other study ID #: RGH-MD-31
• Status: Completed
• Phase: Phase 2
• First received: June 19, 2007
• Last updated: March 2, 2012
• Start date: April 2007
• Est. completion date: August 2008

Study information

• Verified date: March 2012
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationIndia: Ministry of HealthRussia: Ethics CommitteeRussia: Ministry of Health of the Russian FederationRussia: Pharmacological Committee, Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 238
• Est. completion date: August 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male or female inpatients 18 to 65 years of age

• Meeting DSM-IV criteria for bipolar I disorder, acute manic or mixed episode

• Having a total Young Mania Rating Scale (YMRS) score >= 20 and a score of at least 4 on two of the following YMRS items:

• Irritability,

• Speech,

• Content, and

• Disruptive/Aggressive Behavior

Exclusion Criteria:

• Patients who exhibit abnormalities on physical examination, have abnormal vital-signs, ECG, or clinical laboratory values (such as TSH).

• Patients with MADRS total score >= 18 at Visit 2.

• Patients experiencing first manic episode.

• Patients that have received electroconvulsive therapy (ECT) or a depot neuroleptic in the 3 months prior to Visit 1.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Drug:
• Cariprazine (RGH-188)
Cariprazine 3mg - 12mg oral administration, once per day.
• Placebo
Dose-matched placebo. Oral administration, once per day.

Locations

Country	Name	City	State
United States	For information regarding investigative sites, contact Forest Professional Affairs	St. Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Forest Laboratories	Gedeon Richter Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	YMRS		3 Weeks	No
Secondary	CGI-S		3 Weeks	No