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Schizophrenia Study In Adults

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00049946
First Posted: November 18, 2002
Last Update Posted: August 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
GlaxoSmithKline
  Purpose
A Placebo Controlled Study For Patients With Schizophrenia

Condition Intervention Phase
Schizophrenia Drug: talnetant Drug: risperidone Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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:


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
Study Completion Date: April 2003
Primary Completion Date: April 2003 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00049946


  Show 31 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

ClinicalTrials.gov Identifier: NCT00049946     History of Changes
Other Study ID Numbers: SB223412/078
First Submitted: November 15, 2002
First Posted: November 18, 2002
Last Update Posted: August 16, 2017
Last Verified: August 2017

Keywords provided by GlaxoSmithKline:
Talnetant
schizophrenia
NK3 receptor antagonist
psychosis

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents