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

Background: Although case reports andopen studies have reported augmentation with buspirone to bebeneficial in the treatment of depression refractory to treatmentwith a selective serotonin reuptake inhibitor (SSRI), a recentlypublished randomized, placebo-controlled, double-blind studyfailed to show superiority of buspirone over placebo in thisrespect.

Method: One hundred two outpatients whofulfilled DSM-IV criteria for a major depressive episode and whohad failed to respond to a minimum of 6 weeks of treatment witheither fluoxetine or citalopram were included in thisdouble-blind, randomized, placebo-controlled study. After asingle-blind placebo wash-in period of 2 weeks while continuingtheir SSRI, the patients were randomly assigned to adjunctivetreatment with either buspirone, 10 to 30 mg b.i.d., or placebofor 6 weeks. Patients were assessed using the Montgomery-AsbergDepression Rating Scale (MADRS), the Clinical Global Impressionsscale (CGI), and visual analogue scales.

Results: After the first week of double-blindtreatment, there was a significantly greater reduction in MADRSscore (p = .034) in the buspirone group as compared with placebo.At endpoint, there was no significant difference betweentreatment groups as a whole, although patients with initiallyhigh MADRS scores (> 30) showed a significantly greaterreduction in MADRS score (p = .026) in the buspirone group ascompared with placebo.

Conclusion: Patients with severe depressivesymptoms may benefit from augmentation with buspirone. It cannotbe excluded that augmentation with buspirone may speed up theantidepressive response of patients refractory to treatment withfluoxetine or citalopram.