Clinical trial NCT00049946: Schizophrenia Study In Adults
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: Talnetant
schizophrenia
NK3 receptor antagonist
psychosis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2002-11-18
Enrollment: 231
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: A Placebo Controlled Study For Patients With Schizophrenia


Eligibility criteria: Inclusion Criteria:

* Patient must meet diagnostic criteria for schizophrenia.

Exclusion Criteria:

* Patients with other psychotic disorders.
* Patients whose condition is due to the direct physiological effects of a substances (e.g., drug abuse) or a general medical condition.
* Patients with a history of autistic disorder or another pervasive developmental disorder.
* Patients with epilepsy or a history of seizures requiring treatment.
* Patients who are excluded from taking the drug risperidone.
* Patients who pose a current serious suicidal or homicidal risk.
* Patients who are adequately stabilized on their treatment.

Primary outcomes:
measure: Change from baseline in the PANSS total score.
Secondary outcomes:
measure: Secondary measures assessed efficacy, safety & tolerability endpoints using the PANSS, BPRS Psychosis score, CGI-S, CGI-GI, Calgary Depression Scale for Schizophrenia, Brief Assessment of Cognition for Schizophrenia, and others.
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: GSK Clinical Trial Call Center
state: Arizona
city: Cerritos
country: United States
facility: GSK Clinical Trial Call Center
state: California
city: Chula Vista
country: United States
facility: GSK Clinical Trial Call Center
state: California
city: Garden Grove
country: United States
facility: GSK Clinical Trial Call Center
state: California
city: Orange
country: United States
facility: GSK Clinical Trial Call Center
state: California
city: Pico Rivera
country: United States
facility: GSK Clinical Trial Call Center
state: California
city: Rosemead
country: United States
facility: GSK Clinical Trial Call Center
state: California
city: Sacramento
country: United States
facility: GSK Clinical Trial Call Center
state: California
city: San Diego
country: United States
facility: GSK Clinical Trial Call Center
state: California
city: San Diego
country: United States
facility: GSK Clinical Trial Call Center
state: California
city: New Britain
country: United States
facility: GSK Clinical Trial Call Center
state: Connecticut
city: New Haven
country: United States
facility: GSK Clinical Trial Call Center
state: Connecticut
city: Washington, D.C.
country: United States
facility: GSK Clinical Trial Call Center
state: District of Columbia
city: North Miami
country: United States
facility: GSK Clinical Trial Call Center
state: Florida
city: Tampa
country: United States
facility: GSK Clinical Trial Call Center
state: Florida
city: Winter Park
country: United States
facility: GSK Clinical Trial Call Center
state: Florida
city: Hoffman Estates
country: United States
facility: GSK Clinical Trial Call Center
state: Illinois
city: Greenwood
country: United States
facility: GSK Clinical Trial Call Center
state: Indiana
city: Shreveport
country: United States
facility: GSK Clinical Trial Call Center
state: Louisiana
city: Clementon
country: United States
facility: GSK Clinical Trial Call Center
state: New Jersey
city: Hollis
country: United States
facility: GSK Clinical Trial Call Center
state: New York
city: Butner
country: United States
facility: GSK Clinical Trial Call Center
state: North Carolina
city: Raleigh
country: United States
facility: GSK Clinical Trial Call Center
state: North Carolina
city: Cincinnati
country: United States
facility: GSK Clinical Trial Call Center
state: Ohio
city: Cleveland
country: United States
facility: GSK Clinical Trial Call Center
state: Ohio
city: Norman
country: United States
facility: GSK Clinical Trial Call Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: GSK Clinical Trial Call Center
state: Oklahoma
city: Nashville
country: United States
facility: GSK Clinical Trial Call Center
state: Tennessee
city: Austin
country: United States
facility: GSK Clinical Trial Call Center
state: Texas
city: Bellaire
country: United States
facility: GSK Clinical Trial Call Center
state: Texas
city: Terrell
country: United States
facility: GSK Clinical Trial Call Center
state: Texas
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD
role: STUDY_DIRECTOR
References: