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

Forest Laboratories375 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

375

Conditions

Schizophrenia

Interventions

RGH-188DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

For information regarding investigative sites, contact Forest Professional Affairs

St Louis, Missouri, United States

Outcomes

Primary Outcomes

PANSS Total Score

Secondary Outcomes

CGI-S

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.