A Study To Investigate The Antidepressant Effect Of Lamotrigine In Patients With Bipolar Disorder Using Lithium
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
1 other identifier
interventional
120
2 countries
31
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2002
Typical duration for phase_3
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 21, 2005
CompletedFirst Posted
Study publicly available on registry
September 23, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedMay 30, 2017
May 1, 2017
4.1 years
September 21, 2005
May 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Score on the MADRS depression rating scale at week 8 compared to baseline
Secondary Outcomes (1)
Scores on various mood rating scales and safety measurements at week 16 and between week 16 and week 68 compared to baseline
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Actively suicidal.
- Rapid cyclers.
- Suffering from significant personality disorders.
- Alcohol or substance dependent or abusive.
- Suffering from significant physical conditions.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (31)
GSK Investigational Site
Alkmaar, 1815 JD, Netherlands
GSK Investigational Site
Almelo, 7609 PP, Netherlands
GSK Investigational Site
Amersfoort, 3818 EW, Netherlands
GSK Investigational Site
Amsterdam, 1061 AE, Netherlands
GSK Investigational Site
Amsterdam, 1075 GB, Netherlands
GSK Investigational Site
Bennebroek, 2121 AD, Netherlands
GSK Investigational Site
Blaricum, 1261 AN, Netherlands
GSK Investigational Site
Delft, 2625 AD, Netherlands
GSK Investigational Site
Dordrecht, 3317 NM, Netherlands
GSK Investigational Site
Eindhoven, 5623 EJ, Netherlands
GSK Investigational Site
Enschede, 7511JX, Netherlands
GSK Investigational Site
Flushing, 4382 EE, Netherlands
GSK Investigational Site
Gouda, 2803 RT, Netherlands
GSK Investigational Site
Groningen, 9713 GZ, Netherlands
GSK Investigational Site
Hoorn, 1624 NP, Netherlands
GSK Investigational Site
Leiden, 2333 ZB, Netherlands
GSK Investigational Site
Nijmegen, 6532 SZ, Netherlands
GSK Investigational Site
Raalte, 8102 RR, Netherlands
GSK Investigational Site
Retranchement, 4525 LG, Netherlands
GSK Investigational Site
Rosmalen, 5248 NT, Netherlands
GSK Investigational Site
The Hague, 2553 RJ, Netherlands
GSK Investigational Site
Tilburg, 5022 GC, Netherlands
GSK Investigational Site
Utrecht, 3512 PG, Netherlands
GSK Investigational Site
Weert, 6001 BE, Netherlands
GSK Investigational Site
Zwolle, 8025 AB, Netherlands
GSK Investigational Site
Alava, 01004, Spain
GSK Investigational Site
Barcelona, 08025, Spain
GSK Investigational Site
Barcelona, 08035, Spain
GSK Investigational Site
Barcelona, 08036, Spain
GSK Investigational Site
Madrid, 28035, Spain
GSK Investigational Site
Valencia, 46009, Spain
Related Publications (3)
Poster presented at the APA congress, US, 2007 (Lamotrigine as add-on to lithium in bipolar depression) and the 5th European Stanley Conference on Bipolar Disorder in Barcelona, 2006)
BACKGROUNDvan der Loos ML, Mulder PG, Hartong EG, Blom MB, Vergouwen AC, de Keyzer HJ, Notten PJ, Luteijn ML, Timmermans MA, Vieta E, Nolen WA; LamLit Study Group. Efficacy and safety of lamotrigine as add-on treatment to lithium in bipolar depression: a multicenter, double-blind, placebo-controlled trial. J Clin Psychiatry. 2009 Feb;70(2):223-31. doi: 10.4088/jcp.08m04152. Epub 2008 Dec 30.
PMID: 19200421BACKGROUNDvan der Loos ML, Mulder P, Hartong EG, Blom MB, Vergouwen AC, van Noorden MS, Timmermans MA, Vieta E, Nolen WA; LamLit Study Group. Efficacy and safety of two treatment algorithms in bipolar depression consisting of a combination of lithium, lamotrigine or placebo and paroxetine. Acta Psychiatr Scand. 2010 Sep;122(3):246-54. doi: 10.1111/j.1600-0447.2009.01537.x. Epub 2010 Feb 5.
PMID: 20136801DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials, MD
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2005
First Posted
September 23, 2005
Study Start
August 1, 2002
Primary Completion
September 1, 2006
Study Completion
September 1, 2006
Last Updated
May 30, 2017
Record last verified: 2017-05