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

June 19, 2007
March 2, 2012
April 2007
July 2008   (final data collection date for primary outcome measure)
YMRS [ Time Frame: 3 Weeks ] [ Designated as safety issue: No ]
YMRS
Complete list of historical versions of study NCT00488618 on ClinicalTrials.gov Archive Site
CGI-S [ Time Frame: 3 Weeks ] [ Designated as safety issue: No ]
CGI-S
Not Provided
Not Provided
 
Study Evaluating 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

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Bipolar Disorder
  • Drug: Cariprazine (RGH-188)
    Cariprazine 3mg - 12mg oral administration, once per day.
  • Drug: Placebo
    Dose-matched placebo. Oral administration, once per day.
  • Experimental: Cariprazine
    Intervention: Drug: Cariprazine (RGH-188)
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
238
August 2008
July 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00488618
RGH-MD-31
Not Provided
Forest Laboratories
Forest Laboratories
Gedeon Richter Ltd.
Not Provided
Forest Laboratories
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP