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

Tracking Information

First Received Date ^ICMJE

September 21, 2005

Last Updated Date

May 15, 2009

Start Date ^ICMJE

August 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00224510 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

See Detailed Description

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.

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

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Bipolar Depression

Intervention ^ICMJE

Drug: lamotrigine

Study Arms / Comparison Groups

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

120

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Netherlands, Spain

Administrative Information

NCT ID ^ICMJE

NCT00224510

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

SCA30905

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP