Depression And Bipolar Disorder

Phase 3

Completed

• Conditions: Bipolar Disorder
• Interventions: Drug: lamotrigine; Drug: Placebo

• Registration Number: NCT00274677
• Lead Sponsor: GlaxoSmithKline

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

Not available

Study Timeline

• Study Start: 2003-11
• Primary Completion: 2005-08
• Study Completion: 2005-08
• Study First Submitted: 2006-01-09
• Study First Submitted QC: 2006-01-10
• Study First Posted: 2006-01-11
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-13
• Last Update Posted: 2016-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 221

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	lamotrigine	-
lamotrigine	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change from baseline scores at Week 8 for the Montgomery-Asberg Depression Rating Scale (MADRS)	Eight weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Houston, Texas, United States