Topiramate augmentation in patients with resistant major depressive disorder: a
double-blind placebo-controlled clinical trial.
Author(s): Mowla A, Kardeh E.
Affiliation(s): Department of Psychiatry, Bushehr University of Medical Sciences, Bushehr, Iran.
mowlaar@gmail.com
Publication date & source: 2011, Prog Neuropsychopharmacol Biol Psychiatry. , 35(4):970-3
BACKGROUND: Despite evolution of new antidepressant treatment, clinicians still
encounter challenges in the treatment of depressed patients. Looking for new
medications that can potentiate the effects of current antidepressants seems to
be necessary. Our objective is to survey the efficacy of topiramate augmentation
in resistant major depressive disorder (MDD).
METHOD: This augmentation trial was designed as an 8-week randomized,
placebo-controlled, double-blind study. Fifty three patients with DSM-IV
diagnosis of MDD who had failed to respond to at least 8 weeks of treatment with
an adequate dose of one of the SSRIs (fluoxetine, citalopram or serteraline) were
included in the study. Patients were randomized to receive a flexible dose of
topiramate (100-200 mg/day) or placebo beside their current antidepressant
medication for a period of eight weeks. Outcome measures were Hamilton Depression
Scale (HAM-D) and Clinical Global Impression (CGI).
RESULTS: 42 patients completed the study and there were 6 and 5 dropouts in
topiramate and placebo groups, respectively. The topiramate group demonstrated
significant improvement over the study period based on mean HAM-D score at week 8
compared to baseline (P = .000, Z = 3.699). Those receiving topiramate
demonstrated to have a mean decrease of 32.0% in HAM-D score, compared to only
5.5% for those receiving placebo. Depressed mood, suicidality, insomnia (early,
middle and late), agitation and anxiety symptoms were significantly improved in
the topiramate group.
CONCLUSION: Our double-blind placebo-controlled study demonstrated that
topiramate augmentation potentiate the efficacy of selective serotonin reuptake
inhibitors (SSRIs) in treatment of resistant major depressive disorder. Of note
is that our study is preliminary and larger double-blind studies are needed to
confirm the results.
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