title: A placebo-controlled study of nefazodone for the treatment of chronic posttraumatic stress disorder: a preliminary study.
abstract: Nefazodone is a unique serotonergic antidepressant that acts as both a presynaptic serotonin reuptake inhibitor and a postsynaptic 5-hydroxytryptamine 2A receptor antagonist. Based on the positive results of open-label trials of nefazodone, including one from our group, we tested nefazodone's efficacy in the treatment of posttraumatic stress disorder (PTSD) under placebo-controlled conditions. Forty-one patients with chronic PTSD, predominantly male combat veterans, were enrolled in a randomized, double-blind, placebo-controlled 12-week trial of nefazodone. The primary outcome measure was the Clinician-Administered PTSD Scale. Fifteen patients were randomized to placebo and 26 were randomized to nefazodone. In a repeated-measures analysis of variance with last observation carried forward, patients on nefazodone showed a significant improvement in the percentage change of Clinician-Administered PTSD Scale Total score from baseline compared with those on placebo (P = 0.04; effect size = 0.6). Sample size was not powered to test group differences in the Clinician-Administered PTSD Scale criterion B, C, or D subscale. However, the criterion D subscale showed significant improvement in patients treated with nefazodone compared with those treated with placebo (P = 0.007). In addition, the Hamilton Rating Scale for Depression showed significant improvement compared with placebo (P = 0.008). The nefazodone group also reported an improvement on the PTSD Checklist (self-report scale; P = 0.08) and the Clinician-Administered Dissociative States Scale (P = 0.06). This pilot study supports the efficacy of nefazodone for the treatment of PTSD. However, larger placebo-controlled studies in more diverse patient population are warranted.
authors.affiliation: VA Medical Center (151), 3701 Loop Road East, Tuscaloosa, AL 35404, USA. Lori.Davis@med.va.gov
authors.forename: Lori L
authors.initials: LL
authors.lastname: Davis
authors.forename: Michele E
authors.initials: ME
authors.lastname: Jewell
authors.forename: Sandra
authors.initials: S
authors.lastname: Ambrose
authors.forename: Jason
authors.initials: J
authors.lastname: Farley
authors.forename: Brett
authors.initials: B
authors.lastname: English
authors.forename: Al
authors.initials: A
authors.lastname: Bartolucci
authors.forename: Frederick
authors.initials: F
authors.lastname: Petty
mesh_terms: D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D003130:Combat Disorders / Q000188:drug therapy / Q000453:epidemiology / Q000523:psychology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D010879:Piperazines; D012742:Sex Offenses / Q000523:psychology / Q000706:statistics & numerical data; D013313:Stress Disorders, Post-Traumatic / Q000188:drug therapy* / Q000453:epidemiology / Q000523:psychology*; D014230:Triazoles / Q000627:therapeutic use*; D014728:Veterans / Q000523:psychology* / Q000706:statistics & numerical data
chemical_list: D010879:Piperazines; D014230:Triazoles; C051752:nefazodone