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OpenTrials
Completed

NCT Number: NCT00103727

Study Of Talnetant Versus Placebo And Risperidone In Schizophrenia

This study will evaluate whether talnetant (200mg, 400mg, 600mg) twice a day is effective compared to placebo and risperidone 1-3mg twice a day in treating the positive and negative symptoms of schizophrenia. Study subjects will be treated with study drug for up to 6 weeks and will then return for a follow-up visit 2 weeks later. About 275 patients with schizophrenia will be enrolled in this study.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site, Little Rock, Arkansas, 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

  • Subjects must have schizophrenia which is not secondary to another medical condition or substance abuse.
  • Require inpatient hospitalization.
  • Woman may enroll only if they are not of child-bearing potential OR are on a protocol-approved birth control method.

Exclusion criteria

  • Subject is in their first episode of schizophrenia.
  • Subject has other psychotic disorders or bipolar disorder.
  • Subject has schizophrenia symptoms from taking another medicine or drug of abuse, or due to a general medical condition.
  • Subject has a recent history of substance dependence/dependence, or tests positive for illicit drug.
  • Subject has an unstable medical disorder, or any significant medical disorder including autistic disorder, organic brain disease, liver dysfunction, epilepsy or seizures, or is at increased risk of developing cerebrovascular problems like stroke.
  • Subject has any significant abnormalities in any of the screening tests (ECGs, labs, physical examinations, etc.).
  • Subject poses a current serious suicidal or homicidal risk.
  • Subject has a positive pregnancy test, or is lactating or planning to become pregnant within one month of the study.
  • Subject has recently or is currently participating in another clinical study.
  • Subject is stabilized on their current schizophrenia treatment.
  • Subject needs to take any of the medicines not permitted in the study, or has recently had ECT (electroconvulsive therapy) or TMS (transcranial magnetic stimulation).
  • Subject was non-responsive to two or more adequate trials of antipsychotic treatments over the past 2 years.
  • Subject has had an allergic or significant reaction to any of the study drugs, or can't take risperidone.

Treatment and study plan

Talnetant

Drug

talnetant

Placebo

Other

Placebo Comparator

risperidone

Other

Active Comparator

Primary outcomes

  1. The primary outcome measure is change in the Positive and Negative Syndrome Scale (PANSS) at Week 6 compared to baseline values.

    Time frame: 6 weeks

Secondary outcomes

  1. The secondary measures assess both efficacy (cognition, depression) as well as a variety of safety/tolerability endpoints (adverse events, motor function, laboratory measures).

    Time frame: 6 weeks

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
2004
Primary completion
2005
Study completion
2005
First posted
Feb 15, 2005
Registry last updated
Apr 29, 2015

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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