Clinical Study Of Schizophrenia in Both Men and Women
A Multi-Center, Double Blind, Placebo-controlled, Randomized, Parallel Group Evaluation of the Efficacy of a Flexible Dose of Lamotrigine Versus Placebo As Add-On Therapy In Schizophrenia
1 other identifier
interventional
176
1 country
32
Brief Summary
The objective of this study is to evaluate the effectiveness of a marketed drug in the treatment of schizophrenia, as an add-on therapy to antipsychotics over a 12-week period. Subjects with schizophrenia who have been maintained on a stable dose of antipsychotics and who fulfill the screening entrance criteria will have an assessment 1-7 days after the first visit to confirm eligibility.
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 Aug 2003
Shorter than P25 for phase_3 schizophrenia
32 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
August 1, 2003
CompletedFirst Submitted
Initial submission to the registry
October 30, 2003
CompletedFirst Posted
Study publicly available on registry
October 31, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2005
CompletedSeptember 1, 2016
August 1, 2016
October 30, 2003
August 30, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in the total score of the 7 items of the Positive and Negative Symptom Scale (PANSS) positive symptom subscale for lamotrigine vs. placebo at Week 12.
12 Weeks
Secondary Outcomes (1)
Change from baseline in the PANSS total score at Week 12; Change from baseline in the Scale for the Assessment of Negative Symptoms (SANS) at Week 12; Change from baseline in the Clinical Global Impression-Severity of Illness (CGI-S) score at Week 12.
12 Weeks
Interventions
Eligibility Criteria
You may qualify if:
- If female, must not be pregnant, or must be incapable of conceiving or be taking steps to prevent conception.
- Diagnosis of Schizophrenia
- Patients must be taking clozapine monotherapy or other atypical antipsychotic at least 3 months prior to this study.
You may not qualify if:
- Patients who are currently taking or have taken antidepressant medication in the last month prior.
- Patients who are or have been suicidal or homicidal in the last 6 months.
- Patients with a history of autistic disorder or another pervasive developmental disorder
- Patients whose condition is due to the direct physiological effects of a substance (e.g. a drug of abuse, a medication) or a general medical condition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (32)
GSK Investigational Site
Little Rock, Arkansas, 72201, United States
GSK Investigational Site
Garden Grove, California, 92845, United States
GSK Investigational Site
La Mesa, California, 91942, United States
GSK Investigational Site
National City, California, 91950, United States
GSK Investigational Site
Oceanside, California, 92056, United States
GSK Investigational Site
Rosemead, California, 91770, United States
GSK Investigational Site
San Diego, California, 92126, United States
GSK Investigational Site
Hartford, Connecticut, 06106, United States
GSK Investigational Site
Maitland, Florida, 32751, United States
GSK Investigational Site
North Miami, Florida, 33161, United States
GSK Investigational Site
Granite City, Illinois, 62040, United States
GSK Investigational Site
Glen Burnie, Maryland, 21061, United States
GSK Investigational Site
Rockville, Maryland, 20852, United States
GSK Investigational Site
Boston, Massachusetts, 02114, United States
GSK Investigational Site
Reno, Nevada, 89512, United States
GSK Investigational Site
Clementon, New Jersey, 08021, United States
GSK Investigational Site
Kenilworth, New Jersey, 07033, United States
GSK Investigational Site
Orangeburg, New York, 10962, United States
GSK Investigational Site
Rochester, New York, 14620, United States
GSK Investigational Site
Butner, North Carolina, 27509, United States
GSK Investigational Site
Charlotte, North Carolina, 28211, United States
GSK Investigational Site
Raleigh, North Carolina, 27603, United States
GSK Investigational Site
Raleigh, North Carolina, 27609, United States
GSK Investigational Site
Beachwood, Ohio, 44122, United States
GSK Investigational Site
Cleveland, Ohio, 44106, United States
GSK Investigational Site
Lyndhurst, Ohio, 44124, United States
GSK Investigational Site
Norristown, Pennsylvania, 19401, United States
GSK Investigational Site
Austin, Texas, 78756, United States
GSK Investigational Site
Bellaire, Texas, 77401, United States
GSK Investigational Site
DeSoto, Texas, 75115, United States
GSK Investigational Site
Midvale, Utah, 84047, United States
GSK Investigational Site
Milwaukee, Wisconsin, 53226, United States
Related Publications (1)
Goff DC, Keefe R, Citrome L, Davy K, Krystal JH, Large C, Thompson TR, Volavka J, Webster EL. Lamotrigine as add-on therapy in schizophrenia: results of 2 placebo-controlled trials. J Clin Psychopharmacol. 2007 Dec;27(6):582-9. doi: 10.1097/jcp.0b013e31815abf34.
PMID: 18004124BACKGROUND
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
October 30, 2003
First Posted
October 31, 2003
Study Start
August 1, 2003
Study Completion
January 1, 2005
Last Updated
September 1, 2016
Record last verified: 2016-08
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.