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Schizophrenia Study In Adults

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ClinicalTrials.gov Identifier: NCT00049946
Recruitment Status : Completed
First Posted : November 18, 2002
Last Update Posted : August 16, 2017
Sponsor:
Information provided by:
GlaxoSmithKline

Brief Summary:
A Placebo Controlled Study For Patients With Schizophrenia

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: talnetant Drug: risperidone Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 231 participants
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
Study Start Date : October 2002
Actual Primary Completion Date : April 2003
Actual Study Completion Date : April 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Risperidone
U.S. FDA Resources




Primary Outcome Measures :
  1. Change from baseline in the PANSS total score.

Secondary Outcome Measures :
  1. 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.


Information from the National Library of Medicine

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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.

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

ClinicalTrials.gov Identifier: NCT00049946     History of Changes
Other Study ID Numbers: SB223412/078
First Posted: November 18, 2002    Key Record Dates
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