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Completed

NCT Number: NCT00404573

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

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

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

For information regarding investigative sites, contact Forest Professional Affairs

St Louis, Missouri, 63045, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RGH-188

Drug

Primary outcomes

  1. PANSS Total Score

Secondary outcomes

  1. CGI-S

Sponsors and collaborators

Lead sponsor

Forest Laboratories

Industry

Registry information

Official study title

A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of RGH-188 in the Acute Exacerbation of Schizophrenia

Important dates

Study start
2006
Primary completion
2007
First posted
Nov 29, 2006
Registry last updated
Jan 7, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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