Status:
COMPLETED
Study Of An FDA-approved Drug As Additional Therapy In Patients With Schizophrenia
Lead Sponsor:
GlaxoSmithKline
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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.
- Exclusion criteria:
- 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.
Exclusion
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2005
Estimated Enrollment :
209 Patients enrolled
Trial Details
Trial ID
NCT00086593
Start Date
May 1 2004
End Date
July 1 2005
Last Update
October 7 2016
Active Locations (39)
Enter a location and click search to find clinical trials sorted by distance.
1
GSK Investigational Site
Little Rock, Arkansas, United States, 72201
2
GSK Investigational Site
Garden Grove, California, United States, 92845
3
GSK Investigational Site
Glendale, California, United States, 91206
4
GSK Investigational Site
Los Angeles, California, United States, 90033