Study Evaluating RGH-188 in the Treatment of Patients With Schizophrenia

This study has been completed.

First Received: November 27, 2006 Last Updated: January 3, 2008 History of Changes

Sponsored by:	Forest Laboratories
Information provided by:	Forest Laboratories
ClinicalTrials.gov Identifier:	NCT00404573

Purpose

This is a study designed to evalute the safety and efficacy of RGH-188 in the treatment of acute schizophrenia. This study will be 10 weeks in duration; 6 weeks double-blind treatment, and 4 weeks safety follow-up. All patients meeting the eligibility criteria will be randomized to one of the three treatment groups--one of two doses of RGH-188 or placebo

Condition	Intervention	Phase
Schizophrenia	Drug: RGH-188	Phase II

MedlinePlus related topics: Schizophrenia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of RGH-188 in the Acute Exacerbation of Schizophrenia

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:

PANSS Total Score

Secondary Outcome Measures:

CGI-S

Estimated Enrollment:	375
Study Start Date:	November 2006
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Eligibility

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

Criteria

Inclusion Criteria:

Male and female inpatients, 18-65 years of age, meeting DSM-IV-TR criteria for schizophrenia and having a Total Positive and Negative Syndrome Scale (PANSS) Score >=80 and <=120. A score >=4 on item P1 (delusions) or P3 (hallucinatory behavior) and a score of >=4 on item P2 (conceptual disorganization) or P6 (suspiciousness/persecution) of the PNASS

Exclusion Criteria:

Patients with documented disease of the central nervous system that can interfere with the trial assessments, including but not limited to stroke, tumor, Parkinson's, organic brain disease, seizure disorder (except for febrile convulsions during infancy), chronic infection, or neurosyphilis; or patients who have suffered a traumatic brain injury resulting in significant impairment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00404573

Locations

United States, Missouri
For information regarding investigative sites, contact Forest Professional Affairs
St Louis, Missouri, United States, 63045

Sponsors and Collaborators

Forest Laboratories

More Information

No publications provided

Study ID Numbers:	RGH-MD-03
Study First Received:	November 27, 2006
Last Updated:	January 3, 2008
ClinicalTrials.gov Identifier:	NCT00404573 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Forest Laboratories:

Schizophrenia

Study placed in the following topic categories:

Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on May 07, 2009