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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00086593 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Drug: lamotrigine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | 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 |
| Estimated Enrollment: | 210 |
| Study Start Date: | May 2004 |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Contacts and Locations
Hide Study Locations| United States, Arkansas | |
| GSK Investigational Site | |
| Little Rock, Arkansas, United States, 72201 | |
| United States, California | |
| GSK Investigational Site | |
| Garden Grove, California, United States, 92845 | |
| GSK Investigational Site | |
| Sherman Oaks, California, United States, 91403 | |
| GSK Investigational Site | |
| Pico Rivera, California, United States, 90660 | |
| GSK Investigational Site | |
| Glendale, California, United States, 91206 | |
| GSK Investigational Site | |
| San Diego, California, United States, 92126 | |
| GSK Investigational Site | |
| Los Angeles, California, United States, 90033 | |
| United States, Florida | |
| GSK Investigational Site | |
| North Miami, Florida, United States, 33161 | |
| GSK Investigational Site | |
| Maitland, Florida, United States, 32751 | |
| GSK Investigational Site | |
| Coral Springs, Florida, United States, 33065 | |
| GSK Investigational Site | |
| Miami, Florida, United States, 33125 | |
| GSK Investigational Site | |
| Winter Park, Florida, United States, 32789 | |
| United States, Illinois | |
| GSK Investigational Site | |
| Oak Brook, Illinois, United States, 60523 | |
| GSK Investigational Site | |
| Niles, Illinois, United States, 60714 | |
| United States, Indiana | |
| GSK Investigational Site | |
| Indianapolis, Indiana, United States, 46202 | |
| GSK Investigational Site | |
| Indianapolis, Indiana, United States, 46202-5200 | |
| United States, New York | |
| GSK Investigational Site | |
| Staten Island, New York, United States, 10305 | |
| United States, Tennessee | |
| GSK Investigational Site | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| GSK Investigational Site | |
| Bellaire, Texas, United States, 77401 | |
| GSK Investigational Site | |
| San Antonio, Texas, United States, 78229 | |
| United States, Wisconsin | |
| GSK Investigational Site | |
| Madison, Wisconsin, United States, 53711-2027 | |
| Canada, Alberta | |
| GSK Investigational Site | |
| Edmonton, Alberta, Canada, T5K 2J5 | |
| Canada, Manitoba | |
| GSK Investigational Site | |
| Winnipeg, Manitoba, Canada, R3E 3N4 | |
| Canada, New Brunswick | |
| GSK Investigational Site | |
| Miramichi, New Brunswick, Canada, E1V 3G5 | |
| Canada, Nova Scotia | |
| GSK Investigational Site | |
| Dartmouth, Nova Scotia, Canada, B2Y 3S3 | |
| GSK Investigational Site | |
| Sydney, Nova Scotia, Canada, B1S 2E8 | |
| Canada, Ontario | |
| GSK Investigational Site | |
| Sudbury, Ontario, Canada, P3E 1X3 | |
| GSK Investigational Site | |
| Toronto, Ontario, Canada, M6M 3Z5 | |
| GSK Investigational Site | |
| Mississauga, Ontario, Canada, L5M 4N4 | |
| GSK Investigational Site | |
| Burlington, Ontario, Canada, L7N 3V2 | |
| GSK Investigational Site | |
| London, Ontario, Canada, N6A 4G5 | |
| United Kingdom | |
| GSK Investigational Site | |
| Hull, United Kingdom, HU6 7RX | |
| United Kingdom, Bedfordshire | |
| GSK Investigational Site | |
| Bedford, Bedfordshire, United Kingdom, MK42 9DJ | |
| United Kingdom, Cambridgeshire | |
| GSK Investigational Site | |
| Cambridge, Cambridgeshire, United Kingdom, CB1 5EF | |
| United Kingdom, Lanarkshire | |
| GSK Investigational Site | |
| Glasgow, Lanarkshire, United Kingdom, G66 3UG | |
| United Kingdom, Warwickshire | |
| GSK Investigational Site | |
| Coventry, Warwickshire, United Kingdom, CV2 2DX | |
| Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | 101464 |
| Study First Received: | July 6, 2004 |
| Last Updated: | May 15, 2009 |
| ClinicalTrials.gov Identifier: | NCT00086593 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Schizophrenia atypical antipsychotics add-on adjunctive psychosis |
|
Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Calcium Channel Blockers Cardiovascular Agents Antipsychotic Agents Pharmacologic Actions |
Membrane Transport Modulators Schizophrenia Mental Disorders Therapeutic Uses Lamotrigine Central Nervous System Agents Anticonvulsants Schizophrenia and Disorders with Psychotic Features |