Status:
COMPLETED
Effect Of Talnetant Versus Risperidone Versus Placebo On Psychotic Symptoms In Schizophrenic Patients
Lead Sponsor:
GlaxoSmithKline
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to test the safety and effectiveness of talnetant vs. risperidone vs. placebo in reducing positive and negative symptoms in acutely psychotic schizophrenia patients.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Subjects must have schizophrenia which is not secondary to another medical condition or substance abuse.
- Require inpatient hospitalization.
- Women 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, 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.
Exclusion
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
End Date :
October 1 2005
Estimated Enrollment :
275 Patients enrolled
Trial Details
Trial ID
NCT00300963
Start Date
December 1 2004
End Date
October 1 2005
Last Update
February 15 2013
Active Locations (20)
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1
GSK Investigational Site
Little Rock, Arkansas, United States, 72201
2
GSK Investigational Site
Anaheim, California, United States, 92805
3
GSK Investigational Site
Cerritos, California, United States, 90703
4
GSK Investigational Site
Garden Grove, California, United States, 92845