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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00274677 |
Purpose
This study is an 8-week evaluation of an investigational drug for treating depression in bipolar patients. Depressed patients will be given either an investigational drug or placebo and receive psychiatric assessments of their depression at weekly visits. Study drug and all study-related visits are provided at no cost to the patient. The patient agrees to meet with study research staff for roughly 11 clinic visits.
| Condition | Intervention | Phase |
|---|---|---|
|
Bipolar Disorder |
Drug: lamotrigine Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), 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 Major Depression in Patients With Type II Bipolar Disorder |
| Enrollment: | 221 |
| Study Start Date: | November 2003 |
| Study Completion Date: | August 2005 |
| Primary Completion Date: | August 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| lamotrigine: Experimental |
Drug: Placebo
Experimental treatment arm
|
| Placebo: Placebo Comparator |
Drug: lamotrigine
Experimental treatment
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion
Exclusion
Contacts and Locations| United States, California | |
| GSK Investigational Site | |
| San Diego, California, United States, 92108 | |
| GSK Investigational Site | |
| Burbank, California, United States, 91506 | |
| GSK Investigational Site | |
| Loma Linda, California, United States, 92354 | |
| United States, Georgia | |
| GSK Investigational Site | |
| Marietta, Georgia, United States, 30060 | |
| United States, Indiana | |
| GSK Investigational Site | |
| Terre Haute, Indiana, United States, 47802 | |
| United States, Louisiana | |
| GSK Investigational Site | |
| Shreveport, Louisiana, United States, 71101 | |
| United States, Missouri | |
| GSK Investigational Site | |
| St. Charles, Missouri, United States, 63301 | |
| United States, New Jersey | |
| GSK Investigational Site | |
| Princeton, New Jersey, United States, 08540 | |
| GSK Investigational Site | |
| Clementon, New Jersey, United States, 08021 | |
| United States, New York | |
| GSK Investigational Site | |
| New York, New York, United States, 10021 | |
| GSK Investigational Site | |
| Pleasantville, New York, United States, 10570 | |
| United States, North Carolina | |
| GSK Investigational Site | |
| Raleigh, North Carolina, United States, 27609 | |
| GSK Investigational Site | |
| Charlotte, North Carolina, United States, 28209 | |
| United States, Ohio | |
| GSK Investigational Site | |
| Beachwood, Ohio, United States, 44122 | |
| United States, Oklahoma | |
| GSK Investigational Site | |
| Oklahoma City, Oklahoma, United States, 73118 | |
| United States, Oregon | |
| GSK Investigational Site | |
| Eugene, Oregon, United States, 97401 | |
| United States, South Carolina | |
| GSK Investigational Site | |
| Columbia, South Carolina, United States, 29201 | |
| United States, Texas | |
| GSK Investigational Site | |
| Houston, Texas, United States, 77090 | |
| GSK Investigational Site | |
| Galveston, Texas, United States, 77555-0188 | |
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | SCA100223 |
| Study First Received: | January 9, 2006 |
| Last Updated: | May 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00274677 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Bipolar Disorder |
|
Depression Disease Molecular Mechanisms of Pharmacological Action Bipolar Disorder Calcium Channel Blockers Cardiovascular Agents Pharmacologic Actions Behavioral Symptoms Membrane Transport Modulators |
Affective Disorders, Psychotic Pathologic Processes Mental Disorders Therapeutic Uses Mood Disorders Lamotrigine Central Nervous System Agents Anticonvulsants |