Study Of An FDA-approved Drug As Additional Therapy In Patients With Schizophrenia
NCT ID: NCT00086593
Last Updated: 2016-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
209 participants
INTERVENTIONAL
2004-05-31
2005-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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lamotrigine
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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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
GSK Investigational Site
Miramichi, New Brunswick, Canada
GSK Investigational Site
Dartmouth, Nova Scotia, Canada
GSK Investigational Site
Sydney, Nova Scotia, Canada
GSK Investigational Site
Burlington, Ontario, Canada
GSK Investigational Site
Greater Sudbury, Ontario, Canada
GSK Investigational Site
London, Ontario, Canada
GSK Investigational Site
Mississauga, Ontario, Canada
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Windsor, Ontario, Canada
GSK Investigational Site
Bedford, Bedfordshire, United Kingdom
GSK Investigational Site
Cambridge, Cambridgeshire, United Kingdom
GSK Investigational Site
Glasgow, Lanarkshire, United Kingdom
GSK Investigational Site
Coventry, Warwickshire, United Kingdom
GSK Investigational Site
Hull, , United Kingdom
Countries
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Study Documents
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Document Type: Study Protocol
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Dataset Specification
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Informed Consent Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Statistical Analysis Plan
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Clinical Study Report
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Individual Participant Data Set
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentRelated Links
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Other Identifiers
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101464
Identifier Type: -
Identifier Source: org_study_id
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