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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00224510
Recruitment Status : Completed
First Posted : September 23, 2005
Last Update Posted : May 30, 2017
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Bipolar Depression Drug: lamotrigine Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 2002
Actual Primary Completion Date : September 2006
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder
Drug Information available for: Lamotrigine

Primary Outcome Measures :
  1. Score on the MADRS depression rating scale at week 8 compared to baseline

Secondary Outcome Measures :
  1. Scores on various mood rating scales and safety measurements at week 16 and between week 16 and week 68 compared to baseline

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00224510

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GSK Investigational Site
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
Alava, Spain, 01004
GSK Investigational Site
Barcelona, Spain, 08025
GSK Investigational Site
Barcelona, Spain, 08035
GSK Investigational Site
Barcelona, Spain, 08036
GSK Investigational Site
Madrid, Spain, 28035
GSK Investigational Site
Valencia, Spain, 46009
Sponsors and Collaborators
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Study Director: GSK Clinical Trials, MD GlaxoSmithKline
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00224510    
Other Study ID Numbers: SCA30905
First Posted: September 23, 2005    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Keywords provided by GlaxoSmithKline:
bipolar disorder bipolar depression lamotrigine
Additional relevant MeSH terms:
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Depressive Disorder
Bipolar Disorder
Pathologic Processes
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Sodium Channel Blockers