Prophylactic Effect of Lamotrigine Compared With Lithium in Bipolar Disorder

Phase 3

Completed

• Conditions: Bipolar Disorder

• Registration Number: NCT00226135
• Lead Sponsor: University of Aarhus

Brief Summary

The purpose of this study is to compare lamotrigine with lithium in the long term treatment of bipolar disorder in terms of new episode preventive potentials.

Detailed Description

Bipolar disorder is a recurrent lifelong illness. Lithium is still the drug of first choice in the prophylactic treatment. However, lithium's side effects are considerable. Thus the interest in developing alternatives to lithium has increased, and various antiepileptic drugs have been studied. Among these, lamotrigine, which generally is well tolerated, has been evaluated in industry generated trials. However, for various reasons, the generalisability of the results from these studies is limited. Also the follow-up time is limited. This study is a pragmatic effectiveness study, overcoming some of these limitations, and comparing lamotrigine with that of lithium in terms of their potentials for preventing new episodes in patients with bipolar disorder.

Study Timeline

• Study Start: 2001-03
• Study First Submitted: 2005-09-23
• Study First Submitted QC: 2005-09-23
• Study First Posted: 2005-09-26
• Study Completion: 2006-12
• Status Verified: 2007-04
• Last Update Submitted: 2007-04-04
• Last Update Posted: 2007-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to a new mood episode after having succeeded the first 6 month of treatment and reached monotherapy with study drug at that point. New episode defined as symptoms requiring treatment or admission (or suicide).

Secondary Outcome Measures

Name	Time	Method
1: number of patients (ITT population)that completed first 6 months and achieved monotherapy at that time.
2: Number of patients with reported AE (type specified)
3: Number of patients with an endpoint other than censoring (among populations under observation for ½ year, 1 year, 1½ years, 2 years, and 2½ years)
4:The primary end point but selected to patients under observations for 1½ and 2½ years
5: Number of endpoint (other than censoring)among patients reaching 6 months and monotherapy at that time, per person-time(testing for inter-group balance with respect to background variables)

Trial Locations

Locations (1)

Aarhus University Psychiatric Hospital; 🇩🇰 Risskov, Denmark