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Objective: This study reports a clinical trial evaluating
lamotrigine safety and efficacy as an antidepressant augmentation agent in
treatment-resistant depression, therefore adding more empirical evidence
to the limited number of studies on the use of lamotrigine.
Method: A double-blind pilot study was conducted between
March 2004 and January 2006 with 34 nonbipolar, nonpsychotic patients who
had DSM-IV major depressive disorder and were resistant to at least 2
antidepressants. The subjects were taking antidepressant therapy and were
randomly assigned to receive placebo or lamotrigine as an adjunct therapy
for 8 weeks. They were evaluated on a biweekly basis in order to assess
the efficacy and the safety of the drug. Efficacy was measured with the
Montgomery-Asberg Depression Rating Scale (MADRS) and the Clinical Global
Impressions (CGI) scale. Response was defined as a decrease of at least
50% from baseline on the MADRS and a final score <= 2 on the CGI. Safety
was assessed by keeping record of treatment-emergent adverse events.
Results: The results of the adjunct treatment with
lamotrigine did not reveal a significant difference according to the MADRS
(p = .45). No differences between the 2 treatment groups were revealed by
the repeated-measures analysis of variance or by the analysis based on the
CGI (p = .45). More than 50% of the patients had been treated with at
least 3 different antidepressants. The most frequent adverse events were
nausea, rash, and dyspepsia in the lamotrigine group and dizziness and
headache in the placebo group.
Conclusions: In this study, although it was safe,
lamotrigine was not found to be an efficient augmentation agent in
treatment-resistant depression. Small sample size, higher chronicity, and
refractoriness may be related to treatment failure.
Prim Care Companion J Clin Psychiatry 2008;10(3):187-190
https://doi.org/10.4088/PCC.v10n0302
© Copyright 2008 Physicians Postgraduate Press, Inc.