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Trial record 1 of 1 for:    NCT00049946
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Schizophrenia Study In Adults

This study has been completed.
Information provided by:
GlaxoSmithKline Identifier:
First received: November 15, 2002
Last updated: August 14, 2017
Last verified: August 2017
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)

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00049946

  Show 31 Study Locations
Sponsors and Collaborators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information Identifier: NCT00049946     History of Changes
Other Study ID Numbers: SB223412/078
Study First Received: November 15, 2002
Last Updated: August 14, 2017

Keywords provided by GlaxoSmithKline:
NK3 receptor antagonist

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
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 processed this record on September 21, 2017