A Study To Investigate The Antidepressant Effect Of Lamotrigine In Patients With Bipolar Disorder Using Lithium
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bipolar Disorder; Bipolar Depression
Intervention: lamotrigine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline
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.
Clinical Details
Official title: See Detailed Description
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: Score on the MADRS depression rating scale at week 8 compared to baseline
Secondary outcome: Scores on various mood rating scales and safety measurements at week 16 and between week 16 and week 68 compared to baseline
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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
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, Den Haag 2553 RJ, Netherlands
GSK Investigational Site, Dordrecht 3317 NM, Netherlands
GSK Investigational Site, Eindhoven 5623 EJ, Netherlands
GSK Investigational Site, Enschede 7511JX, 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, Tilburg 5022 GC, Netherlands
GSK Investigational Site, Utrecht 3512 PG, Netherlands
GSK Investigational Site, Vlissingen 4382 EE, 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
Additional Information
Related publications: 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) van 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. Epub 2008 Dec 30.
Starting date: August 2002
Last updated: March 17, 2011
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