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OpenTrials
Completed

NCT Number: NCT00049946

Schizophrenia Study In Adults

A Placebo Controlled Study For Patients With Schizophrenia

Completed

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Key information

Conditions

Schizophrenia Mental Disorders Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Clinical Trial Call Center, Scottsdale, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Talnetant

Drug

Risperidone

Drug

Primary outcomes

  1. Change from baseline in the PANSS total score.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Nov 18, 2002
Registry last updated
Aug 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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