A Multicenter, Double-Blind, Placebo-Controlled, Fixed-Dose, 8-Week Evaluation of the Efficacy and Safety of Lamotrigine in the Treatment of Depression in Patients With Type II Bipolar Disorder

GlaxoSmithKline1 site in 1 country221 target enrollmentNovember 2003

ConditionsBipolar Disorder

Interventionslamotrigine Placebo

DrugsPlacebo lamotrigine

Overview

Phase: Phase 3
Intervention: lamotrigine
Conditions: Bipolar Disorder
Sponsor: GlaxoSmithKline
Enrollment: 221
Locations: 1
Primary Endpoint: Change from baseline scores at Week 8 for the Montgomery-Asberg Depression Rating Scale (MADRS)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2003

End Date

August 2005

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

Placebo

Intervention: lamotrigine

lamotrigine

Intervention: Placebo

Outcomes

Primary Outcomes

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

Time Frame: Eight weeks

Secondary Outcomes

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)(Eight weeks)