Depression And Bipolar Disorder - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Depression And Bipolar Disorder

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

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 ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

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

Secondary Outcome Measure ^†

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)

Condition ^†

Bipolar Disorder

Intervention ^†

Drug: lamotrigine

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

220

Start Date ^†

December 2003

Completion Date

Eligibility 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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00274677

Organization ID

SCA100223

Secondary IDs ^††

Study Sponsor ^†

GlaxoSmithKline

Collaborators ^††

Investigators ^†

Study Director:

GSK Clinical Trial, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

September 2006

First Received Date ^†

January 9, 2006

Last Updated Date

September 27, 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.