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

This study has been completed.

Sponsor:

Collaborator:

Gedeon Richter Ltd.

Information provided by (Responsible Party):

Forest Laboratories

ClinicalTrials.gov Identifier:

NCT00488618

First received: June 19, 2007

Last updated: March 2, 2012

Last verified: March 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	June 19, 2007
Last Updated Date	March 2, 2012
Start Date ^ICMJE	April 2007
Primary Completion Date	July 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 2, 2012)	YMRS [ Time Frame: 3 Weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: June 19, 2007)	YMRS
Change History	Complete list of historical versions of study NCT00488618 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 2, 2012)	CGI-S [ Time Frame: 3 Weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE (submitted: June 19, 2007)	CGI-S
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study Evaluating RGH-188 in the Treatment of Patients With Acute Mania
Official Title ^ICMJE	A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of RGH-188 in Patients With Acute Mania Associated With Bipolar I Disorder
Brief 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
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Bipolar Disorder
Intervention ^ICMJE	Drug: Cariprazine (RGH-188) Cariprazine 3mg - 12mg oral administration, once per day. Drug: Placebo Dose-matched placebo. Oral administration, once per day.
Study Arm (s)	Experimental: Cariprazine Intervention: Drug: Cariprazine (RGH-188) Placebo Comparator: Placebo Intervention: Drug: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	238
Completion Date	August 2008
Primary Completion Date	July 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00488618
Other Study ID Numbers ^ICMJE	RGH-MD-31
Has Data Monitoring Committee	Not Provided
Responsible Party	Forest Laboratories
Study Sponsor ^ICMJE	Forest Laboratories
Collaborators ^ICMJE	Gedeon Richter Ltd.
Investigators ^ICMJE	Not Provided
Information Provided By	Forest Laboratories
Verification Date	March 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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