A double-blind placebo-controlled study of lamotrigine monotherapy in outpatients with bipolar I depression. Lamictal 602 Study Group.

Abstract

BACKGROUND:

More treatment options for bipolar depression are needed. Currently available antidepressants may increase the risk of mania and rapid cycling, and mood stabilizers appear to be less effective in treating depression than mania. Preliminary data suggest that lamotrigine, an established antiepileptic drug, may be effective for both the depression and mania associated with bipolar disorder. This is the first controlled multicenter study evaluating lamotrigine monotherapy in the treatment of bipolar I depression.

METHODS:

Outpatients with bipolar I disorder experiencing a major depressive episode (DSM-IV, N = 195) received lamotrigine (50 or 200 mg/day) or placebo as monotherapy for 7 weeks. Psychiatric evaluations, including the Hamilton Rating Scale for Depression (HAM-D), the Montgomery-Asberg Depression Rating Scale (MADRS), Mania Rating Scale, and the Clinical Global Impressions scale for Severity (CGI-S) and Improvement (CGI-I) were completed at each weekly visit.

RESULTS:

Lamotrigine 200 mg/day demonstrated significant antidepressant efficacy on the 17-item HAM-D, HAM-D Item 1, MADRS, CGI-S, and CGI-I compared with placebo. Improvements were seen as early as week 3. Lamotrigine 50 mg/day also demonstrated efficacy compared with placebo on several measures. The proportions of patients exhibiting a response on CGI-I were 51%, 41%, and 26% for lamotrigine 200 mg/day, lamotrigine 50 mg/day, and placebo groups, respectively. Adverse events and other safety results were similar across treatment groups, except for a higher rate of headache in the lamotrigine groups.

CONCLUSION:

Lamotrigine monotherapy is an effective and well-tolerated treatment for bipolar depression.

• Authors: J R Calabrese, C L Bowden, G S Sachs, J A Ascher, E Monaghan, G D Rudd
• Journal: The Journal of clinical psychiatry (J Clin Psychiatry) Vol. 60 Issue 2 Pg. 79-88 (Feb 1999) ISSN: 0160-6689 [Print] United States
• PMID: 10084633 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anticonvulsants
• Placebos
• Triazines
• Lamotrigine

Topics

• Adult
• Aged
• Ambulatory Care
• Anticonvulsants (adverse effects, therapeutic use)
• Bipolar Disorder (drug therapy, psychology)
• Depressive Disorder (drug therapy, psychology)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Drug Administration Schedule
• Female
• Humans
• Lamotrigine
• Male
• Middle Aged
• Patient Compliance
• Placebos
• Psychiatric Status Rating Scales
• Severity of Illness Index
• Treatment Outcome
• Triazines (adverse effects, therapeutic use)