Depression And Bipolar Disorder - Full Text View

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	Phase III

MedlinePlus related topics:

Bipolar Disorder Depression

Drug Information available for:

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 Major Depression in Patients With Type II Bipolar Disorder

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)

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)

Estimated Enrollment:	220
Study Start Date:	December 2003

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

Show 23 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trial, MD	GlaxoSmithKline

More Information

Study ID Numbers:	SCA100223
First Received:	January 9, 2006
Last Updated:	September 27, 2006
ClinicalTrials.gov Identifier:	NCT00274677
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Bipolar Disorder

Study placed in the following topic categories:

Affective Disorders, Psychotic

Depression

Mental Disorders

Bipolar Disorder

Lamotrigine

Mood Disorders

Psychotic Disorders

Depressive Disorder, Major

Depressive Disorder

Behavioral Symptoms

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 November 20, 2008

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00274677