Depression And Bipolar Disorder

Condition(s) targeted: Bipolar Disorder

Intervention: lamotrigine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trial, MD, Study Director, Affiliation: GlaxoSmithKline

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.

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

Study design: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change from baseline scores at Week 8 for the Montgomery-Asberg Depression Rating Scale (MADRS)

Secondary outcome: 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)

Minimum age: 18 Years. Gender(s): Both.

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.

GSK Clinical Trials Call Center, San Diego, California 92108, United States

GSK Clinical Trials Call Center, Beverly Hills, California 90210, United States

GSK Clinical Trials Call Center, Los Angeles, California 90048, United States

GSK Clinical Trials Call Center, Santa Ana, California 92705, United States

GSK Clinical Trials Call Center, Marietta, Georgia 30060, United States

GSK Clinical Trials Call Center, Terre Haute, Indiana 47802, United States

GSK Clinical Trials Call Center, Florence, Kentucky 41042, United States

GSK Clinical Trials Call Center, Shreveport, Louisiana 71101, United States

GSK Clinical Trials Call Center, St. Charles, Missouri 63301, United States

GSK Clinical Trials Call Center, Princeton, New Jersey 08540, United States

GSK Clinical Trials Call Center, Clementon, New Jersey 08021, United States

GSK Clinical Trials Call Center, Bronx, New York 10467, United States

GSK Clinical Trials Call Center, New York, New York 10021, United States

GSK Clinical Trials Call Center, Raleigh, North Carolina 27609, United States

GSK Clinical Trials Call Center, Charlotte, North Carolina 28226, United States

GSK Clinical Trials Call Center, Cleveland, Ohio 44016, United States

GSK Clinical Trials Call Center, Beachwood, Ohio 44122, United States

GSK Clinical Trials Call Center, Oklahoma, Oklahoma 73118, United States

GSK Clinical Trials Call Center, Portland, Oregon 97210, United States

GSK Clinical Trials Call Center, Eugene, Oregon 97401, United States

GSK Clinical Trials Call Center, Columbia, South Carolina 29201, United States

GSK Clinical Trials Call Center, Galveston, Texas 77090, United States

GSK Clinical Trials Call Center, Houston, Texas 77058, United States

Starting date: December 2003
Last updated: September 27, 2006