Schizophrenia Study In Adults

This study has been completed.

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

Sponsored by:	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:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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: 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 32 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

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

Keywords provided by GlaxoSmithKline:

Talnetant
schizophrenia
NK3 receptor antagonist
psychosis

Study placed in the following topic categories:

Neurotransmitter Agents
Tranquilizing Agents
Risperidone
Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Serotonin

Schizophrenia
Dopamine
Mental Disorders
Psychotic Disorders
Dopamine Agents
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Risperidone
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents

Pharmacologic Actions
Schizophrenia
Serotonin Antagonists
Serotonin Agents
Mental Disorders
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on July 02, 2009