Bipolar Disorder Study for Men and Women - Full Text View

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

MedlinePlus related topics:

Bipolar Disorder Depression

ChemIDplus related topics:

Lamotrigine

U.S. FDA Resources

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

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

Study ID Numbers:	SCA30924
First Received:	March 10, 2003
Last Updated:	June 26, 2007
ClinicalTrials.gov Identifier:	NCT00056277
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Affective Disorders, Psychotic

Depression

Mental Disorders

Bipolar Disorder

Lamotrigine

Mood Disorders

Psychotic Disorders

Additional relevant MeSH terms:

Membrane Transport Modulators

Pathologic Processes

Disease

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Calcium Channel Blockers

Cardiovascular Agents

Central Nervous System Agents

Anticonvulsants

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 07, 2008

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00056277