Schizophrenia Study In Adults

August 14, 2017 updated by: GlaxoSmithKline

A Multicenter, Double-Blind, Double-Dummy, Placebo-Controlled, Randomized, Parallel Group Evaluation of the Efficacy and Safety of a Fixed-Dose of Talnetant Versus Placebo Versus Risperidone in Subjects With Schizophrenia

A Placebo Controlled Study For Patients With Schizophrenia

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

231

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85251
        • GSK Clinical Trial Call Center
    • California
      • Cerritos, California, United States, 90703
        • GSK Clinical Trial Call Center
      • Chula Vista, California, United States, 91910
        • GSK Clinical Trial Call Center
      • Garden Grove, California, United States, 92845
        • GSK Clinical Trial Call Center
      • Orange, California, United States, 92868
        • GSK Clinical Trial Call Center
      • Pico Rivera, California, United States, 90660
        • GSK Clinical Trial Call Center
      • Rosemead, California, United States, 91770
        • GSK Clinical Trial Call Center
      • Sacramento, California, United States, 95823
        • GSK Clinical Trial Call Center
      • San Diego, California, United States, 92123
        • GSK Clinical Trial Call Center
      • San Diego, California, United States, 92126
        • GSK Clinical Trial Call Center
    • Connecticut
      • New Britain, Connecticut, United States, 06050
        • GSK Clinical Trial Call Center
      • New Haven, Connecticut, United States, 06519
        • GSK Clinical Trial Call Center
    • District of Columbia
      • Washington, D.C., District of Columbia, United States, 20016
        • GSK Clinical Trial Call Center
    • Florida
      • North Miami, Florida, United States, 33161
        • GSK Clinical Trial Call Center
      • Tampa, Florida, United States, 33613
        • GSK Clinical Trial Call Center
      • Winter Park, Florida, United States, 32789
        • GSK Clinical Trial Call Center
    • Illinois
      • Hoffman Estates, Illinois, United States, 60194
        • GSK Clinical Trial Call Center
    • Indiana
      • Greenwood, Indiana, United States, 46143
        • GSK Clinical Trial Call Center
    • Louisiana
      • Shreveport, Louisiana, United States, 71101
        • GSK Clinical Trial Call Center
    • New Jersey
      • Clementon, New Jersey, United States, 08021
        • GSK Clinical Trial Call Center
    • New York
      • Hollis, New York, United States, 11423
        • GSK Clinical Trial Call Center
    • North Carolina
      • Butner, North Carolina, United States, 27509
        • GSK Clinical Trial Call Center
      • Raleigh, North Carolina, United States, 27603
        • GSK Clinical Trial Call Center
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • GSK Clinical Trial Call Center
      • Cleveland, Ohio, United States, 44109
        • GSK Clinical Trial Call Center
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • GSK Clinical Trial Call Center
      • Oklahoma City, Oklahoma, United States, 73103
        • GSK Clinical Trial Call Center
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • GSK Clinical Trial Call Center
    • Texas
      • Austin, Texas, United States, 78729
        • GSK Clinical Trial Call Center
      • Bellaire, Texas, United States, 77401
        • GSK Clinical Trial Call Center
      • Terrell, Texas, United States, 75160
        • GSK Clinical Trial Call Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient must meet diagnostic criteria for schizophrenia.

Exclusion Criteria:

  • Patients with other psychotic disorders.
  • Patients whose condition is due to the direct physiological effects of a substances (e.g., drug abuse) or a general medical condition.
  • Patients with a history of autistic disorder or another pervasive developmental disorder.
  • Patients with epilepsy or a history of seizures requiring treatment.
  • Patients who are excluded from taking the drug risperidone.
  • Patients who pose a current serious suicidal or homicidal risk.
  • Patients who are adequately stabilized on their treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change from baseline in the PANSS total score.

Secondary Outcome Measures

Outcome Measure
Secondary measures assessed efficacy, safety & tolerability endpoints using the PANSS, BPRS Psychosis score, CGI-S, CGI-GI, Calgary Depression Scale for Schizophrenia, Brief Assessment of Cognition for Schizophrenia, and others.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Primary Completion (Actual)

April 1, 2003

Study Completion (Actual)

April 1, 2003

Study Registration Dates

First Submitted

November 15, 2002

First Submitted That Met QC Criteria

November 15, 2002

First Posted (Estimate)

November 18, 2002

Study Record Updates

Last Update Posted (Actual)

August 16, 2017

Last Update Submitted That Met QC Criteria

August 14, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SB223412/078

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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