Safety and Efficacy of RGH-188 in the Acute Exacerbation of Schizophrenia - Full Text View

Sponsors and Collaborators:	Forest Laboratories Gedeon Richter Ltd.
Information provided by:	Forest Laboratories
ClinicalTrials.gov Identifier:	NCT00694707

Purpose

This is an study to evaluate the safety, efficacy, and tolerability of RGH-188 relative to placebo in adult patients (18-60 years of age) with acute exacerbation of schizophrenia.

Condition	Intervention	Phase
Schizophrenia	Drug: Placebo Drug: RGH-188 Drug: Risperidone	Phase II

MedlinePlus related topics: Schizophrenia

Drug Information available for: Risperidone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

16-item Negative Symptom Assessment (NSA-16) test score [ Time Frame: Week 6 ] [ Designated as safety issue: No ]

Estimated Enrollment:	675
Study Start Date:	June 2008
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Placebo, oral administration, once daily dosing for 6 weeks	Drug: Placebo Placebo oral administration once daily for 6 weeks
2: Experimental RGH-188 low dose, oral administration, once daily dosing for 6 weeks	Drug: RGH-188 RGH-188 low dose once daily for 6 weeks
3: Experimental RGH-188 medium dose, oral administration, once daily dosing for 6 weeks	Drug: RGH-188 RGH-188 medium dose once daily for six weeks
4: Experimental RGH-188 high dose, oral administration, once daily dosing for 6 weeks	Drug: RGH-188 RGH-188 high dose oral administration once daily for six weeks
5: Active Comparator Active comparator, oral administration, once daily dosing for 6 weeks	Drug: Risperidone Risperidone oral administration once daily for six weeks

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female 18 to 60 years of age
meeting DSM-IV criteria for schizophrenia (paranoid type, disorganized type, catatonic type or undifferentiated type) based on the SCID
having a total PANSS score greater than or equal to 80 and less than or equal to 120
Patients with a schizophrenia diagnosis for a minimum of 1 year.

Exclusion Criteria:

Patients who exhibit abnormalities on Physical Examination, have abnormal vital signs, ECG, or clinical laboratory values.
Patients experiencing first episode of psychosis.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00694707

Contacts

Contact: Sandra Beaird, PhD

1-800-678-1605 ext 66297

info@forestpharm.com

Locations

United States, California
Forest Investigative Site	Recruiting
Paramount, California, United States, 90723
Forest Investigative Site	Recruiting
Long Beach, California, United States, 90813
Forest Investigative Site	Not yet recruiting
Oceanside, California, United States, 92056
Forest Investigative Site	Not yet recruiting
Costa Mesa, California, United States, 92626
Forest Investigative Site	Not yet recruiting
Riverside, California, United States, 92506
United States, District of Columbia
Forest Investigative Site	Recruiting
Washington, District of Columbia, United States, 20016
United States, Florida
Forest Investigative Site	Recruiting
Kissimee, Florida, United States, 34741
Forest Investigative Site	Recruiting
Bradenton, Florida, United States, 34208
United States, Georgia
Forest Investigative Site	Recruiting
Atlanta, Georgia, United States, 30329
United States, Louisiana
Forest Investigative Site	Recruiting
Lake Charles, Louisiana, United States, 70601
United States, Maryland
Forest Investigative Site	Recruiting
Baltimore, Maryland, United States, 21202
United States, Mississippi
Forest Investigative Site	Not yet recruiting
Flowood, Mississippi, United States, 39232
United States, Missouri
Forest Investigative Site	Recruiting
Bridgeton, Missouri, United States, 63044
United States, New York
Forest Investigative Site	Recruiting
New York, New York, United States, 10032
United States, Ohio
Forest Investigative Site	Recruiting
Cincinnati, Ohio, United States, 45219
United States, South Carolina
Forest Investigative Site	Recruiting
Charleston, South Carolina, United States, 29405
United States, Tennessee
Forest Investigative Site	Recruiting
Memphis, Tennessee, United States, 28117
United States, Texas
Forest Investigative Site	Recruiting
Irving, Texas, United States, 75062
Forest Investigative Site	Recruiting
Houston, Texas, United States, 77008
Forest Investigative Site	Recruiting
Houston, Texas, United States, 77021

Sponsors and Collaborators

Forest Laboratories

Gedeon Richter Ltd.

Investigators

Study Director:

Kelly Papadakis, MD

Forest Laboratories

More Information

Responsible Party:	Forest Laboratories ( Kelly Papadakis, MD Study Director )
Study ID Numbers:	RGH-MD-16
Study First Received:	June 6, 2008
Last Updated:	December 18, 2008
ClinicalTrials.gov Identifier:	NCT00694707
Health Authority:	United States: Food and Drug Administration; India: Ministry of Health; Russia: Ministry of Health and Social Development of the Russian Federation; Malaysia: Ministry of Health; Ukraine: Ministry of Health; Bulgaria: Bulgarian Drug Agency

Study placed in the following topic categories:

Schizophrenia
Dopamine
Mental Disorders
Risperidone

Psychotic Disorders
Serotonin
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Dopamine Antagonists

Antipsychotic Agents
Pharmacologic Actions
Serotonin Antagonists
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009