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

GlaxoSmithKline120 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

120

Conditions

Bipolar Disorder Bipolar Depression

Interventions

lamotrigineDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (31)

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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