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

Condition(s) targeted: 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

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.

Official title: 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 design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

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.

GSK Clinical Trials Call Center, Utrecht 3582 AC, Netherlands

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Starting date: June 2002
Last updated: June 9, 2008