Study Of An FDA-approved Drug As Additional Therapy In Patients With Schizophrenia

Completed · Phase 3

Conditions studied: Schizophrenia

In brief

This is a 12-week study for the treatment of chronic persistent symptoms in participants with schizophrenia. Participants on a stable, optimal dose of up to two atypical antipsychotics who fulfill the screening criteria will be randomized to receive either an FDA-approved drug or placebo in addition to the current treatment. Safety will be closely monitored through vital signs, various tests, and blood and urine samples.

Key facts

Study ID

NCT00086593

Run by

GlaxoSmithKline

People needed

209

Starts

2004-05-01

Expected to finish

2005-07-01

Last updated by the study team

2016-10-07

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed with schizophrenia.
• Exhibits persistent positive symptoms that have persisted for a minimum of 3 months prior to screening.
• Continuously taking 1-2 specific atypical antipsychotics for a minimum of 3 months and must be on a stable dose for at least 1 month prior to entering the study.
• Participant or a legal guardian is able to understand and sign the consent form.

You may not qualify if…

• PANSS (Positive and Negative Syndrome Score) total score increases or decreases by more than 20% between the Screening and Baseline visits.
• Predominant Axis I disorder other than schizophrenia within 6 months prior to screening.
• History of clinically significant or unstable medical disorder or treatment that would interfere with the study.
• History of autistic disorder or another pervasive developmental disorder, organic brain disease, dementia, stroke, epilepsy or a history of seizures requiring treatment (this does not include febrile seizures as a child), or those who have suffered a traumatic head injury.
• Taking psychotropic or primarily centrally active medication at screening.
• Use of antidepressant medications or mood stabilizers within 1 month of screening.

Where it is running

• GSK Investigational Site — Little Rock, Arkansas, United States
• GSK Investigational Site — Garden Grove, California, United States
• GSK Investigational Site — Glendale, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Pico Rivera, California, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — Sherman Oaks, California, United States
• GSK Investigational Site — Coral Springs, Florida, United States
• GSK Investigational Site — Maitland, Florida, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — North Miami, Florida, United States
• GSK Investigational Site — Winter Park, Florida, United States
• GSK Investigational Site — Niles, Illinois, United States
• GSK Investigational Site — Oak Brook, Illinois, United States
• GSK Investigational Site — Indianapolis, Indiana, United States
• GSK Investigational Site — Indianapolis, Indiana, United States
• GSK Investigational Site — Staten Island, New York, United States
• GSK Investigational Site — Nashville, Tennessee, United States
• GSK Investigational Site — Bellaire, Texas, United States
• GSK Investigational Site — San Antonio, Texas, United States
• GSK Investigational Site — Madison, Wisconsin, United States
• GSK Investigational Site — Edmonton, Alberta, Canada
• GSK Investigational Site — Edmonton, Alberta, Canada
• GSK Investigational Site — Kelowna, British Columbia, Canada
• GSK Investigational Site — Winnipeg, Manitoba, Canada

Full record on ClinicalTrials.gov

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