A Study To Investigate The Antidepressant Effect Of Lamotrigine In Patients With Bipolar Disorder Using Lithium

Phase 3

Completed

• Conditions: Bipolar Disorder; Bipolar Depression

• Registration Number: NCT00224510
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This is a study that, in the first 16 weeks, investigates whether lamotrigine versus placebo offers effect on depressive episodes for patients with bipolar disorder (also known as manic depressive disorder) who use lithium. In the following 50 weeks it is investigated whether these patients experience effect on their depressive and/ or (hypo)manic episodes.

Detailed Description

A Multicentre, Double-Blind, Randomised, Fixed-Dose Evaluation of the Safety and Efficacy of Lamotrigine (Lamictal®) compared to placebo as add-on therapy to lithium in the Treatment of Bipolar Depression followed by Long-term Prevention of Relapse and Recurrence of Depression and/or Mania in Subjects With Bipolar Disorder

Study Timeline

• Study Start: 2002-08
• Study First Submitted: 2005-09-21
• Study First Submitted QC: 2005-09-21
• Study First Posted: 2005-09-23
• Primary Completion: 2006-09
• Study Completion: 2006-09
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-24
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Score on the MADRS depression rating scale at week 8 compared to baseline

Secondary Outcome Measures

Name	Time	Method
Scores on various mood rating scales and safety measurements at week 16 and between week 16 and week 68 compared to baseline

Trial Locations

Locations (1)

GSK Investigational Site; 🇪🇸 Valencia, Spain