Clinical trial NCT00103727: Study Of Talnetant Versus Placebo And Risperidone In Schizophrenia
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Keywords: paranoid
catatonic
undifferentiated types
disorganized
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-02-15
Enrollment: 282
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: The primary outcome measure is change in the Positive and Negative Syndrome Scale (PANSS) at Week 6 compared to baseline values.
timeFrame: 6 weeks
Secondary outcomes:
measure: The secondary measures assess both efficacy (cognition, depression) as well as a variety of safety/tolerability endpoints (adverse events, motor function, laboratory measures).
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Anaheim
country: United States
facility: GSK Investigational Site
state: California
city: Cerritos
country: United States
facility: GSK Investigational Site
state: California
city: Garden Grove
country: United States
facility: GSK Investigational Site
state: California
city: Glendale
country: United States
facility: GSK Investigational Site
state: California
city: National City
country: United States
facility: GSK Investigational Site
state: California
city: Oceanside
country: United States
facility: GSK Investigational Site
state: California
city: Pico Rivera
country: United States
facility: GSK Investigational Site
state: California
city: Rosemead
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: Upland
country: United States
facility: GSK Investigational Site
state: California
city: Washington
country: United States
facility: GSK Investigational Site
state: District of Columbia
city: North Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Oak Brook
country: United States
facility: GSK Investigational Site
state: Illinois
city: St. Louis
country: United States
facility: GSK Investigational Site
state: Missouri
city: Clementon
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
city: Irving
country: United States
facility: GSK Investigational Site
state: Texas
city: Richmond
country: United States
facility: GSK Investigational Site
state: Virginia
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: