Prophylactic Effect of Lamotrigine Compared With Lithium in Bipolar Disorder
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Lamotrigine Versus Lithium in Subjects With Bipolar Affective Disorders - a Randomised Study of Prophylactic Effect|
- 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).
- 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)
|Study Start Date:||March 2001|
|Study Completion Date:||December 2006|
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.
|Aarhus University Psychiatric Hospital|
|Risskov, Denmark, 8240|
|Principal Investigator:||Rasmus W Licht, MD, PhD||Aarhus University Psychiatric Hospital, Risskov, Denmark|