Bipolar Disorder Study: Lamotrigine in the Treatment of Bipolar Disorder Patients
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on May 08, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bipolar Disorder
Intervention: lamotrigine (Drug)
Phase: Phase 3
Status: No longer recruiting
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline
Summary
This is a placebo controlled study evaluating the efficacy and safety of medication in patients with bipolar disorder.
Clinical Details
Official title:
A Multicenter, Double-Blind, Placebo-Controlled, Fixed-Dose, 8-Week Evaluation of the Efficacy and Safety of Lamotrigine in the Treatment of Bipolar Disorder Patients Currently Experiencing a Major Depressive Episode
Study design: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change from baseline scores at Week 8 for the Montgomery-Asberg Depression Rating Scale (MADRS)
Secondary outcome: Change from baseline scores at Week 8 for the Hamilton Depression Rating Scale (HAMD-17, HAMD-31, Bech Melancholia Scale [BMS], and HAMD - Item 1), Clinical Global Impressions of Severity (CGI-S) and Improvement (CGI-I)
Eligibility
Minimum age: 18 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients must provide written informed consent
- Diagnosis of bipolar I disorder and currently depressed for minimum of the previous 8 weeks
- Patients must have been hospitalized for mood disorder or incarceration with or without formal charges as the result of mania related behavior
Exclusion Criteria:
- Patients must not be suicidal
- Patients must not have a history of non-response to antidepressant treatment
- Patients must not have a clinical history of substance dependence in the past year or abuse within the 4 weeks prior to study entry
- Patients must not have had epilepsy or hypothyroidism
Locations and Contacts
GSK Clinical Trials Call Center, San Diego, California 92018, United States
GSK Clinical Trials Call Center, Beverly Hills, California 90210, United States
GSK Clinical Trials Call Center, Los Angeles, California 90048, United States
GSK Clinical Trials Call Center, Santa Ana, California 92705, United States
GSK Clinical Trials Call Center, Marietta, Georgia 30060, United States
GSK Clinical Trials Call Center, Terre Haute, Indiana 47802, United States
GSK Clinical Trials Call Center, Florence, Kentucky 41042, United States
GSK Clinical Trials Call Center, Princeton, New Jersey 08540-2859, United States
GSK Clinical Trials Call Center, Bronx, New York 10467, United States
GSK Clinical Trials Call Center, New York, New York 10021, United States
GSK Clinical Trials Call Center, Raleigh, North Carolina 27609, United States
GSK Clinical Trials Call Center, Cleveland, Ohio 44106, United States
GSK Clinical Trials Call Center, Beachwood, Ohio 44122, United States
GSK Clinical Trials Call Center, Eugene, Oregon 97401, United States
GSK Clinical Trials Call Center, Portland, Oregon 92710, United States
GSK Clinical Trials Call Center, Columbia, South Carolina 29201, United States
GSK Clinical Trials Call Center, Houston, Texas 77090, United States
GSK Clinical Trials Call Center, Brown Deer, Wisconsin 53223, United States
Additional Information
Starting date:
November 2003
Last updated: January 19, 2006
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