NCT Number: NCT00300963
Effect Of Talnetant Versus Risperidone Versus Placebo On Psychotic Symptoms In Schizophrenic Patients
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.
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Conditions
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
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.
- 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.
Treatment and study plan
Primary outcomes
-
The primary outcome measure is change in the Positive and Negative Syndrome Scale (PANSS) at Week 6 compared to baseline values.
Secondary outcomes
-
The secondary measures assess both efficacy (cognition, depression) as well as a variety of safety/tolerability endpoints (adverse events, motor function, laboratory measures).
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
- Mar 10, 2006
- Registry last updated
- Feb 15, 2013
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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