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
  Purpose

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


Condition Intervention Phase
Bipolar Disorder
Drug: Cariprazine (RGH-188)
Drug: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • YMRS [ Time Frame: 3 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CGI-S [ Time Frame: 3 Weeks ] [ Designated as safety issue: No ]

Enrollment: 238
Study Start Date: April 2007
Study Completion Date: August 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cariprazine Drug: Cariprazine (RGH-188)
Cariprazine 3mg - 12mg oral administration, once per day.
Placebo Comparator: Placebo Drug: Placebo
Dose-matched placebo. Oral administration, once per day.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00488618

Locations
United States, Missouri
For information regarding investigative sites, contact Forest Professional Affairs
St. Louis, Missouri, United States, 63045
Sponsors and Collaborators
Forest Laboratories
Gedeon Richter Ltd.
  More Information

No publications provided

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT00488618     History of Changes
Other Study ID Numbers: RGH-MD-31
Study First Received: June 19, 2007
Last Updated: March 2, 2012
Health Authority: United States: Food and Drug Administration
India: Ministry of Health
Russia: Ethics Committee
Russia: Ministry of Health of the Russian Federation
Russia: Pharmacological Committee, Ministry of Health

Keywords provided by Forest Laboratories:
Mania
Bipolar I Disorder
Acute Mania Associated with Bipolar I Disorder

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 19, 2014