Study Of An FDA-approved Drug As Additional Therapy In Patients With Schizophrenia
A Multicenter, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive Therapy to an Atypical Antipsychotic Agent(s) in Subjects With Schizophrenia
1 other identifier
interventional
209
3 countries
39
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 schizophrenia
Started May 2004
Shorter than P25 for phase_3 schizophrenia
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
July 6, 2004
CompletedFirst Posted
Study publicly available on registry
July 8, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2005
CompletedOctober 7, 2016
October 1, 2016
1.2 years
July 6, 2004
October 5, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in the total score of the Positive and Negative Symptom Scale (PANSS) at Week 12.
12 Weeks
Secondary Outcomes (1)
- Efficacy - Change from baseline in PANSS positive symptoms at Week 12 - Change from baseline in the Scale for the Assessment of Negative Symptoms (SANS) at Week 12 - Change from baseline in PANSS general psychopathology symptoms at Week 12.
12 Weeks
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (39)
GSK Investigational Site
Little Rock, Arkansas, 72201, United States
GSK Investigational Site
Garden Grove, California, 92845, United States
GSK Investigational Site
Glendale, California, 91206, United States
GSK Investigational Site
Los Angeles, California, 90033, United States
GSK Investigational Site
Pico Rivera, California, 90660, United States
GSK Investigational Site
San Diego, California, 92126, United States
GSK Investigational Site
Sherman Oaks, California, 91403, United States
GSK Investigational Site
Coral Springs, Florida, 33065, United States
GSK Investigational Site
Maitland, Florida, 32751, United States
GSK Investigational Site
Miami, Florida, 33125, United States
GSK Investigational Site
North Miami, Florida, 33161, United States
GSK Investigational Site
Winter Park, Florida, 32789, United States
GSK Investigational Site
Niles, Illinois, 60714, United States
GSK Investigational Site
Oak Brook, Illinois, 60523, United States
GSK Investigational Site
Indianapolis, Indiana, 46202-5200, United States
GSK Investigational Site
Indianapolis, Indiana, 46202, United States
GSK Investigational Site
Staten Island, New York, 10305, United States
GSK Investigational Site
Nashville, Tennessee, 37203, United States
GSK Investigational Site
Bellaire, Texas, 77401, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
Madison, Wisconsin, 53711-2027, United States
GSK Investigational Site
Edmonton, Alberta, T5K 2J5, Canada
GSK Investigational Site
Edmonton, Alberta, T6G 2C8, Canada
GSK Investigational Site
Kelowna, British Columbia, V1W 4V5, Canada
GSK Investigational Site
Winnipeg, Manitoba, R3E 3N4, Canada
GSK Investigational Site
Miramichi, New Brunswick, E1V 3G5, Canada
GSK Investigational Site
Dartmouth, Nova Scotia, B2Y 3S3, Canada
GSK Investigational Site
Sydney, Nova Scotia, B1S 2E8, Canada
GSK Investigational Site
Burlington, Ontario, L7N 3V2, Canada
GSK Investigational Site
Greater Sudbury, Ontario, P3E 1X3, Canada
GSK Investigational Site
London, Ontario, N6A 4G5, Canada
GSK Investigational Site
Mississauga, Ontario, L5M 4N4, Canada
GSK Investigational Site
Toronto, Ontario, M6M 3Z5, Canada
GSK Investigational Site
Windsor, Ontario, N9C 3Z4, Canada
GSK Investigational Site
Bedford, Bedfordshire, MK42 9DJ, United Kingdom
GSK Investigational Site
Cambridge, Cambridgeshire, CB1 5EF, United Kingdom
GSK Investigational Site
Glasgow, Lanarkshire, G66 3UG, United Kingdom
GSK Investigational Site
Coventry, Warwickshire, CV2 2DX, United Kingdom
GSK Investigational Site
Hull, HU6 7RX, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 6, 2004
First Posted
July 8, 2004
Study Start
May 1, 2004
Primary Completion
July 1, 2005
Study Completion
July 1, 2005
Last Updated
October 7, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.