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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00056277 |
Purpose
A Placebo Controlled Study Evaluating Efficacy and Safety of Medication in Patients with Bipolar Disorder
| Condition | Intervention | Phase |
|---|---|---|
|
Bipolar Disorder |
Drug: lamotrigine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 150 |
| Study Start Date: | November 2003 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| GSK Clinical Trials Call Center | |
| San Diego, California, United States, 92018 | |
| GSK Clinical Trials Call Center | |
| Beverly Hills, California, United States, 90210 | |
| GSK Clinical Trials Call Center | |
| Los Angeles, California, United States, 90048 | |
| GSK Clinical Trials Call Center | |
| Santa Ana, California, United States, 92705 | |
| United States, Georgia | |
| GSK Clinical Trials Call Center | |
| Marietta, Georgia, United States, 30060 | |
| United States, Indiana | |
| GSK Clinical Trials Call Center | |
| Terre Haute, Indiana, United States, 47802 | |
| United States, Kentucky | |
| GSK Clinical Trials Call Center | |
| Florence, Kentucky, United States, 41042 | |
| United States, New Jersey | |
| GSK Clinical Trials Call Center | |
| Princeton, New Jersey, United States, 08540-2859 | |
| United States, New York | |
| GSK Clinical Trials Call Center | |
| Bronx, New York, United States, 10467 | |
| GSK Clinical Trials Call Center | |
| New York, New York, United States, 10021 | |
| United States, North Carolina | |
| GSK Clinical Trials Call Center | |
| Raleigh, North Carolina, United States, 27609 | |
| United States, Ohio | |
| GSK Clinical Trials Call Center | |
| Cleveland, Ohio, United States, 44106 | |
| GSK Clinical Trials Call Center | |
| Beachwood, Ohio, United States, 44122 | |
| United States, Oregon | |
| GSK Clinical Trials Call Center | |
| Eugene, Oregon, United States, 97401 | |
| GSK Clinical Trials Call Center | |
| Portland, Oregon, United States, 92710 | |
| United States, South Carolina | |
| GSK Clinical Trials Call Center | |
| Columbia, South Carolina, United States, 29201 | |
| United States, Texas | |
| GSK Clinical Trials Call Center | |
| Houston, Texas, United States, 77090 | |
| United States, Wisconsin | |
| GSK Clinical Trials Call Center | |
| Brown Deer, Wisconsin, United States, 53223 | |
| Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
More Information
| Study ID Numbers: | SCA30924 |
| Study First Received: | March 10, 2003 |
| Last Updated: | June 26, 2007 |
| ClinicalTrials.gov Identifier: | NCT00056277 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Disease Molecular Mechanisms of Pharmacological Action Bipolar Disorder Calcium Channel Blockers Cardiovascular Agents Pharmacologic Actions Membrane Transport Modulators Affective Disorders, Psychotic |
Pathologic Processes Mental Disorders Therapeutic Uses Mood Disorders Lamotrigine Central Nervous System Agents Anticonvulsants |