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

May 24, 2017 updated by: GlaxoSmithKline

A Mulitcentre, Double-blind, Randomised, Fixed-dose Evaluation of the Safety and Efficacy of Lamictal (Lamotrigine) Compared to Placebo as an add-on Therapy to Lithium or Another Mood Stabiliser in the Treatment of Bipolar Depression, Followed by Long-term Prevention of Relapse and Recurrence of Depression and/or Mania in Patients With Bipolar Disorder

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Alkmaar, Netherlands, 1815 JD
        • GSK Investigational Site
      • Almelo, Netherlands, 7609 PP
        • GSK Investigational Site
      • Amersfoort, Netherlands, 3818 EW
        • GSK Investigational Site
      • Amsterdam, Netherlands, 1061 AE
        • GSK Investigational Site
      • Amsterdam, Netherlands, 1075 GB
        • GSK Investigational Site
      • Bennebroek, Netherlands, 2121 AD
        • GSK Investigational Site
      • Blaricum, Netherlands, 1261 AN
        • GSK Investigational Site
      • Delft, Netherlands, 2625 AD
        • GSK Investigational Site
      • Den Haag, Netherlands, 2553 RJ
        • GSK Investigational Site
      • Dordrecht, Netherlands, 3317 NM
        • GSK Investigational Site
      • Eindhoven, Netherlands, 5623 EJ
        • GSK Investigational Site
      • Enschede, Netherlands, 7511JX
        • GSK Investigational Site
      • Gouda, Netherlands, 2803 RT
        • GSK Investigational Site
      • Groningen, Netherlands, 9713 GZ
        • GSK Investigational Site
      • Hoorn, Netherlands, 1624 NP
        • GSK Investigational Site
      • Leiden, Netherlands, 2333 ZB
        • GSK Investigational Site
      • Nijmegen, Netherlands, 6532 SZ
        • GSK Investigational Site
      • Raalte, Netherlands, 8102 RR
        • GSK Investigational Site
      • Retranchement, Netherlands, 4525 LG
        • GSK Investigational Site
      • Rosmalen, Netherlands, 5248 NT
        • GSK Investigational Site
      • Tilburg, Netherlands, 5022 GC
        • GSK Investigational Site
      • Utrecht, Netherlands, 3512 PG
        • GSK Investigational Site
      • Vlissingen, Netherlands, 4382 EE
        • GSK Investigational Site
      • Weert, Netherlands, 6001 BE
        • GSK Investigational Site
      • Zwolle, Netherlands, 8025 AB
        • GSK Investigational Site
  • Spain
      • Alava, Spain, 01004
        • GSK Investigational Site
      • Barcelona, Spain, 08025
        • GSK Investigational Site
      • Barcelona, Spain, 08036
        • GSK Investigational Site
      • Barcelona, Spain, 08035
        • GSK Investigational Site
      • Madrid, Spain, 28035
        • GSK Investigational Site
      • Valencia, Spain, 46009
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Patients with bipolar disorder (type I or type II) currently suffering from depression that is at least moderate in severity according to a psychiatrist.
  • Currently using lithium.
  • Female subjects can't be pregnant or become pregnant during the study.

Exclusion criteria:

  • Actively suicidal.
  • Rapid cyclers.
  • Suffering from significant personality disorders.
  • Alcohol or substance dependent or abusive.
  • Suffering from significant physical conditions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Score on the MADRS depression rating scale at week 8 compared to baseline

Secondary Outcome Measures

Outcome Measure
Scores on various mood rating scales and safety measurements at week 16 and between week 16 and week 68 compared to baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2002

Primary Completion (Actual)

September 1, 2006

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

September 21, 2005

First Submitted That Met QC Criteria

September 21, 2005

First Posted (Estimate)

September 23, 2005

Study Record Updates

Last Update Posted (Actual)

May 30, 2017

Last Update Submitted That Met QC Criteria

May 24, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCA30905

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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