Patients With Severe Depression May Benefit From Buspirone Augmentation of Selective Serotonin Reuptake Inhibitors: Results From a Placebo-Controlled, Randomized, Double-Blind, Placebo Wash-In Study
J Clin Psychiatry 2001;62(6):448-452
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Background: Although case reports and
open studies have reported augmentation with buspirone to be
beneficial in the treatment of depression refractory to treatment
with a selective serotonin reuptake inhibitor (SSRI), a recently
published randomized, placebo-controlled, double-blind study
failed to show superiority of buspirone over placebo in this
Method: One hundred two outpatients who
fulfilled DSM-IV criteria for a major depressive episode and who
had failed to respond to a minimum of 6 weeks of treatment with
either fluoxetine or citalopram were included in this
double-blind, randomized, placebo-controlled study. After a
single-blind placebo wash-in period of 2 weeks while continuing
their SSRI, the patients were randomly assigned to adjunctive
treatment with either buspirone, 10 to 30 mg b.i.d., or placebo
for 6 weeks. Patients were assessed using the Montgomery-Asberg
Depression Rating Scale (MADRS), the Clinical Global Impressions
scale (CGI), and visual analogue scales.
Results: After the first week of double-blind
treatment, there was a significantly greater reduction in MADRS
score (p = .034) in the buspirone group as compared with placebo.
At endpoint, there was no significant difference between
treatment groups as a whole, although patients with initially
high MADRS scores (> 30) showed a significantly greater
reduction in MADRS score (p = .026) in the buspirone group as
compared with placebo.
Conclusion: Patients with severe depressive
symptoms may benefit from augmentation with buspirone. It cannot
be excluded that augmentation with buspirone may speed up the
antidepressive response of patients refractory to treatment with
fluoxetine or citalopram.