Clinical Study Of Schizophrenia in Both Men and Women

Condition(s) targeted: Schizophrenia

Intervention: lamotrigine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trial, MD, Study Director, Affiliation: GlaxoSmithKline

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.

Official title: 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

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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.

Secondary outcome: 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.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion criteria: 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. Exclusion criteria: 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

GSK Clinical Trial Call Center, Little Rock, Arkansas 72211, United States

GSK Clinical Trial Call Center, Rosemead, California 91770, United States

GSK Clinical Trial Call Center, Garden Grove, California 90804, United States

GSK Clinical Trial Call Center, San Diego, California 92126, United States

GSK Clinical Trial Call Center, La Mesa, California 91942, United States

GSK Clinical Trial Call Center, Oceanside, California 92056, United States

GSK Clinical Trial Call Center, San Diego, California 92105, United States

GSK Clinical Trial Call Center, Hartford, Connecticut 06106, United States

GSK Clinical Trial Call Center, North Miami, Florida 33161, United States

GSK Clinical Trial Call Center, Winter Park, Florida 32789, United States

GSK Clinical Trial Call Center, Ft. Lauderdale, Florida 33161, United States

GSK Clinical Trial Call Center, Atlanta, Georgia 30308, United States

GSK Clinical Trial Call Center, Granite City, Illinois 62040, United States

GSK Clinical Trial Call Center, Glen Burnie, Maryland 21061, United States

GSK Clinical Trial Call Center, Rockville, Maryland 20850, United States

GSK Clinical Trial Call Center, Boston, Massachusetts 02114, United States

GSK Clinical Trial Call Center, Reno, Nevada 89512, United States

GSK Clinical Trial Call Center, Clementon, New Jersey 08021, United States

GSK Clinical Trial Call Center, Kenilworth, New Jersey 07033, United States

GSK Clinical Trial Call Center, Rochester, New York 14620, United States

GSK Clinical Trial Call Center, Orangeburg, New York 10962, United States

GSK Clinical Trial Call Center, Charlotte, North Carolina 28211, United States

GSK Clinical Trial Call Center, Raleigh, North Carolina 27603, United States

GSK Clinical Trial Call Center, Butner, North Carolina 27509, United States

GSK Clinical Trial Call Center, Durham, North Carolina 27609, United States

GSK Clinical Trial Call Center, Cleveland, Ohio 44106, United States

GSK Clinical Trial Call Center, Beachwood, Ohio 44122, United States

GSK Clinical Trial Call Center, Lyndhurst, Ohio 44124, United States

GSK Clinical Trial Call Center, Norristown, Pennsylvania 19401, United States

GSK Clinical Trial Call Center, Austin, Texas 78756, United States

GSK Clinical Trial Call Center, Bellaire, Texas 77401, United States

GSK Clinical Trial Call Center, DeSoto, Texas 75115, United States

GSK Clinical Trial Call Center, Salt Lake City, Utah 84117, United States

GSK Clinical Trial Call Center, Milwaukee, Wisconsin 53226, United States

Starting date: August 2003
Last updated: June 25, 2007