Antidepressant efficacy in HIV-seropositive outpatients with major depressive disorder: An open trial of nefazodone

Background: Treatment studies of major depression in patients who are serop ositive for the human immunodeficiency virus (HIV) have shown comparable ef ficacy for both tricyclic antidepressants (TCAs) and selective serotonin re uptake inhibitors (SSRIs). Nefazodone appears to be more tolerable than TCA s and similar to SSRIs. This study examined the efficacy and tolerability o f nefazodone in an open 12-week trial of HIV-seropositive outpatients with major depressive disorder. Method: Fifteen HN-seropositive patients with DSM-IV major depressive disor der and a 21-item Hamilton Rating Scale for Depression (HAM-D) score of gre ater than or equal to 18 were treated a with open-label nefazodone for 12 w eeks. Hamilton Rating Scale for Anxiety, HAM-D, Clinical Global Impressions scale, and Systematic Assessment for Treatment Emergent Events general inq uiry (for safety and tolerability) scores were obtained at weeks 2, 4, 6, 8 , and 12. Results: Of 15 patients receiving nefazodone, 4 discontinued treatment (1 f or adverse effects). Of 11 patients who completed the trial, 8 (73%) were c lassified as full responders with a 50% reduction in HAM-D scores and final CGI score of 1 or 2, and 10 (91%) were classified as partial responders (o nly 50% reduction in HAM-D scores). Nefazodone-treated subjects experienced fev; total adverse effects (mean = 1.5), no sexual side effects, and low r ates of adverse-effect-related dropout (1 subject, 7%). Conclusion: Depressed HIV-seropositive out-patients respond to nefazodone c omparably to other outpatient populations and have few adverse effects, sug gesting that nefazodone may have a role in the treatment of depression in H N-seropositive patients. Potential drug interactions with protease inhibito rs indicate that it is essential to evaluate for appropriate dosing to avoi d adverse effects and increase overall antidepressant efficacy.