Depression And Bipolar Disorder - Tabular View

Tracking Information

First Received Date ^ICMJE

January 9, 2006

Last Updated Date

May 29, 2009

Start Date ^ICMJE

November 2003

Primary Completion Date

August 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change from baseline scores at Week 8 for the Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00274677 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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).

Descriptive Information

Brief Title ^ICMJE

Depression And Bipolar Disorder

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Bipolar Disorder

Intervention ^ICMJE

Drug: lamotrigine
Drug: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

221

Completion Date

August 2005

Primary Completion Date

August 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00274677

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

SCA100223

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP