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

NCT ID: NCT00224510

Last Updated: 2017-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-08-31

Study Completion Date

2006-09-30

Brief Summary

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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

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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

Conditions

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Bipolar Disorder Bipolar Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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lamotrigine

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials, MD

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Alkmaar, , Netherlands

Site Status

GSK Investigational Site

Almelo, , Netherlands

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Amersfoort, , Netherlands

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Amsterdam, , Netherlands

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Amsterdam, , Netherlands

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Bennebroek, , Netherlands

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Blaricum, , Netherlands

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Delft, , Netherlands

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Dordrecht, , Netherlands

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Eindhoven, , Netherlands

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Enschede, , Netherlands

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Flushing, , Netherlands

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Gouda, , Netherlands

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Groningen, , Netherlands

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Hoorn, , Netherlands

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Leiden, , Netherlands

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Nijmegen, , Netherlands

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Raalte, , Netherlands

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Retranchement, , Netherlands

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Rosmalen, , Netherlands

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The Hague, , Netherlands

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Tilburg, , Netherlands

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Utrecht, , Netherlands

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Weert, , Netherlands

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Zwolle, , Netherlands

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GSK Investigational Site

Alava, , Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Madrid, , Spain

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GSK Investigational Site

Valencia, , Spain

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Countries

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Netherlands Spain

References

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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)

Reference Type BACKGROUND

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. doi: 10.4088/jcp.08m04152. Epub 2008 Dec 30.

Reference Type BACKGROUND
PMID: 19200421 (View on PubMed)

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. doi: 10.1111/j.1600-0447.2009.01537.x. Epub 2010 Feb 5.

Reference Type DERIVED
PMID: 20136801 (View on PubMed)

Other Identifiers

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SCA30905

Identifier Type: -

Identifier Source: org_study_id

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