Schizophrenia Study In Adults

This study has been completed.

First Received on November 15, 2002. Last Updated on April 17, 2006 History of Changes

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00049946

Purpose

A Placebo Controlled Study For Patients With Schizophrenia

Condition	Intervention	Phase
Schizophrenia	Drug: talnetant Drug: risperidone	Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Mental Disorders Psychotic Disorders Schizophrenia

Drug Information available for: Risperidone SB 223412

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Change from baseline in the PANSS total score.

Secondary Outcome Measures:

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.

Estimated Enrollment:	231
Study Start Date:	October 2002

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00049946

Show 31 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00049946 History of Changes
Other Study ID Numbers:	SB223412/078
Study First Received:	November 15, 2002
Last Updated:	April 17, 2006
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Talnetant
schizophrenia
NK3 receptor antagonist
psychosis

Additional relevant MeSH terms:

Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on February 12, 2012