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

Bipolar Disorder Clinical Trial

Official title:

A Mulitcentre, Double-blind, Randomised, Fixed-dose Evaluation of the Safety and Efficacy of Lamictal (Lamotrigine) Compared to Placebo as an add-on Therapy to Lithium or Another Mood Stabiliser in the Treatment of Bipolar Depression, Followed by Long-term Prevention of Relapse and Recurrence of Depression and/or Mania in Patients With Bipolar Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00224510
• Other study ID #: SCA30905
• Status: Completed
• Phase: Phase 3
• First received: September 21, 2005
• Last updated: May 24, 2017
• Start date: August 2002
• Est. completion date: September 2006

Study information

• Verified date: May 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Depression
• Bipolar Disorder
• Depression
• Depressive Disorder
• Disease

Intervention

Drug:
• lamotrigine

Locations

Country	Name	City	State
Netherlands	GSK Investigational Site	Alkmaar
Netherlands	GSK Investigational Site	Almelo
Netherlands	GSK Investigational Site	Amersfoort
Netherlands	GSK Investigational Site	Amsterdam
Netherlands	GSK Investigational Site	Amsterdam
Netherlands	GSK Investigational Site	Bennebroek
Netherlands	GSK Investigational Site	Blaricum
Netherlands	GSK Investigational Site	Delft
Netherlands	GSK Investigational Site	Den Haag
Netherlands	GSK Investigational Site	Dordrecht
Netherlands	GSK Investigational Site	Eindhoven
Netherlands	GSK Investigational Site	Enschede
Netherlands	GSK Investigational Site	Gouda
Netherlands	GSK Investigational Site	Groningen
Netherlands	GSK Investigational Site	Hoorn
Netherlands	GSK Investigational Site	Leiden
Netherlands	GSK Investigational Site	Nijmegen
Netherlands	GSK Investigational Site	Raalte
Netherlands	GSK Investigational Site	Retranchement
Netherlands	GSK Investigational Site	Rosmalen
Netherlands	GSK Investigational Site	Tilburg
Netherlands	GSK Investigational Site	Utrecht
Netherlands	GSK Investigational Site	Vlissingen
Netherlands	GSK Investigational Site	Weert
Netherlands	GSK Investigational Site	Zwolle
Spain	GSK Investigational Site	Alava
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Netherlands,  Spain, 

References & Publications (2)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score on the MADRS depression rating scale at week 8 compared to baseline
Secondary	Scores on various mood rating scales and safety measurements at week 16 and between week 16 and week 68 compared to baseline