Schizophrenia Study In Adults

This study has been completed.

Sponsor:

Information provided by:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00049946

First received: November 15, 2002

Last updated: February 11, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

November 15, 2002

Last Updated Date

February 11, 2013

Start Date ^ICMJE

October 2002

Primary Completion Date

April 2003 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change from baseline in the PANSS total score.

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00049946 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Schizophrenia Study In Adults

Official Title ^ICMJE

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

Brief Summary

A Placebo Controlled Study For Patients With Schizophrenia

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Schizophrenia

Intervention ^ICMJE

Drug: talnetant
Drug: risperidone

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

231

Completion Date

April 2003

Primary Completion Date

April 2003 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00049946

Other Study ID Numbers ^ICMJE

SB223412/078

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top