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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

Page last updated: August 23, 2015

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