Bipolar Disorder Study for Men and Women - Full Text View

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

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder Depression

Drug Information available for: Lamotrigine

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Change from baseline scores at Week 8 for the Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 8 Weeks ]

Secondary Outcome Measures:

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). [ Time Frame: 8 Weeks ]

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

Criteria

Inclusion Criteria:

Patients must provide written and 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 or 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00056277

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

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

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

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on February 04, 2010