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

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00224510

Purpose

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	Intervention	Phase
Bipolar Disorder Bipolar Depression	Drug: lamotrigine	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	See Detailed Description

Resource links provided by NLM:

MedlinePlus related topics: Antidepressants Bipolar Disorder Depression

Drug Information available for: Lamotrigine

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	120
Study Start Date:	August 2002

Intervention Details:

Other Name: lamotrigine

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00224510

Locations

Netherlands
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, 1075 GB
GSK Investigational Site
Amsterdam, Netherlands, 1061 AE
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
Spain
GSK Investigational Site
Alava, Spain, 01004
GSK Investigational Site
Barcelona, Spain, 08036
GSK Investigational Site
Barcelona, Spain, 08035
GSK Investigational Site
Barcelona, Spain, 08025
GSK Investigational Site
Madrid, Spain, 28035
GSK Investigational Site
Valencia, Spain, 46009

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Publications:

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

van 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. Epub 2010 Feb 5.

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00224510 History of Changes
Other Study ID Numbers:	SCA30905
Study First Received:	September 21, 2005
Last Updated:	March 17, 2011
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by GlaxoSmithKline:

bipolar disorder bipolar depression lamotrigine

Additional relevant MeSH terms:

Bipolar Disorder
Depression
Depressive Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Lamotrigine

Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anticonvulsants

ClinicalTrials.gov processed this record on February 12, 2012