Depression And Bipolar Disorder - Full Text View

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: Placebo Drug: lamotrigine	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

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: Eight weeks ] [ Designated as safety issue: No ]

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: Eight weeks ] [ Designated as safety issue: No ]

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
Placebo Comparator: Placebo	Drug: lamotrigine Experimental treatment Other Name: Placebo
Experimental: lamotrigine	Drug: Placebo Experimental treatment arm Other Name: placebo

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion

Patients must provide written and informed consent.
Diagnosis of Bipolar II Disorder and currently depressed for minimum of the last 8 weeks.

Exclusion

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00274677

Locations

United States, California
GSK Investigational Site
Burbank, California, United States, 91506
GSK Investigational Site
Loma Linda, California, United States, 92354
GSK Investigational Site
San Diego, California, United States, 92108
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
Clementon, New Jersey, United States, 08021
GSK Investigational Site
Princeton, New Jersey, United States, 08540
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
Charlotte, North Carolina, United States, 28209
GSK Investigational Site
Raleigh, North Carolina, United States, 27609
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
Galveston, Texas, United States, 77555-0188
GSK Investigational Site
Houston, Texas, United States, 77090

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00274677 History of Changes
Obsolete Identifiers:	NCT00076882
Other Study ID Numbers:	SCA100223
Study First Received:	January 9, 2006
Last Updated:	May 19, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Bipolar Disorder

Additional relevant MeSH terms:

Bipolar Disorder
Depression
Depressive Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms
Lamotrigine

Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Anticonvulsants
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 13, 2012