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CompletedNCT00103727Updated Apr 29, 2015

Study Of Talnetant Versus Placebo And Risperidone In Schizophrenia

A Phase 2 interventional study of Talnetant and placebo in Schizophrenia, sponsored by GlaxoSmithKline. Completed at 22 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-04-29.

Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
282
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Schizophrenia

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Keywords

  • paranoid
  • catatonic
  • undifferentiated types
  • disorganized
03

In context

Schizophrenia

3,470 studies on the registry are indexed under Schizophrenia; 471 are open to participants now.

This study's enrollment of 282 is above the median of 70 across 2,871 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
282 participants (actual)

Study arms

  • Experimental
    talnetant

    200mg, 400mg, 600mg) twice a day

    Drug: Talnetant

  • Placebo comparator
    placebo

    placebo

    Other: placebo

  • Active comparator
    risperidone

    3mg twice a day

    Other: risperidone

Interventions

  • DrugTalnetant

    talnetant

  • Otherplacebo

    Placebo Comparator

  • Otherrisperidone

    Active Comparator

06

What researchers measure

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

07

Study locations

22 sites
  • GSK Investigational Site
    Little Rock, Arkansas 72201, United States
  • GSK Investigational Site
    Anaheim, California 92805, United States
  • GSK Investigational Site
    Cerritos, California 90703, United States
  • GSK Investigational Site
    Garden Grove, California 92845, United States
  • GSK Investigational Site
    Glendale, California 91206, United States
  • GSK Investigational Site
    National City, California 91950, United States
  • GSK Investigational Site
    Oceanside, California 92056, United States
  • GSK Investigational Site
    Pico Rivera, California 90660, United States
  • GSK Investigational Site
    Rosemead, California 91770, United States
  • GSK Investigational Site
    San Diego, California 92123, United States
  • GSK Investigational Site
    San Diego, California 92126, United States
  • GSK Investigational Site
    Upland, California 91786, United States
  • GSK Investigational Site
    Washington, District of Columbia 20016, United States
  • GSK Investigational Site
    North Miami, Florida 33161, United States
  • GSK Investigational Site
    Atlanta, Georgia 30308, United States
  • GSK Investigational Site
    Oak Brook, Illinois 60523, United States
  • GSK Investigational Site
    St. Louis, Missouri 63118, United States
  • GSK Investigational Site
    Clementon, New Jersey 08021, United States
  • GSK Investigational Site
    Philadelphia, Pennsylvania 19131, United States
  • GSK Investigational Site
    Austin, Texas 78756, United States
  • GSK Investigational Site
    Irving, Texas 75062, United States
  • GSK Investigational Site
    Richmond, Virginia 23294, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00103727
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Feb 15, 2005
Start date
Dec 2004
Primary completion
Oct 2005
Completion
Oct 2005
Last update
Apr 29, 2015

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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