title: Double-blind placebo-controlled pilot study of sertraline in military veterans with posttraumatic stress disorder.
abstract: The efficacy of sertraline in the treatment of civilian posttraumatic stress disorder (PTSD) has been established by two large placebo-controlled trials. The purpose of the current pilot study was to obtain preliminary evidence of the efficacy of sertraline in military veterans suffering from PTSD. Outpatient Israeli military veterans with a DSM-III-R diagnosis of PTSD were randomized to 10 weeks of double-blind treatment with sertraline (50-200 mg/day; N = 23, 83% male, mean age = 41 years) or placebo (N = 19, 95% male, mean age = 38 years). Efficacy was evaluated by the Clinician-Administered PTSD Scale (CAPS-2) and by Clinical Global Impression Scale-Severity (CGI-S) and -Improvement (CGI-I) ratings. Consensus responder criteria consisted of a 30% or greater reduction in the CAPS-2 total severity score and a CGI-I rating of "much" or "very much" improved. The baseline CAPS-2 total severity score was 94.3 +/- 12.9 for sertraline patients, which is notably higher than that reported for most studies of civilian PTSD. On an intent-to-treat endpoint analysis, sertraline showed a numeric but not statistically significant advantage compared with placebo on the CAPS-2 total severity and symptom cluster scores. In the study completer analysis, the mean CGI-I score was 2.4 +/- 0.3 for sertraline and 3.4 +/- 0.3 for placebo (t = 2.55, df = 30, p = 0.016), CGI-I responder rates were 53% for sertraline and 20% for placebo (chi2 = 3.62, df = 1, p = 0.057), and combined CGI-I and CAPS-2 responder rates (>or=30% reduction in baseline CAPS-2 score) were 41% for sertraline and 20% for placebo (chi2 = 1.39, df = 1, p = 0.238). Sertraline treatment was well tolerated, with a 13% discontinuation rate as a result of adverse events. This pilot study suggests that sertraline may be an effective treatment in patients with predominantly combat-induced PTSD, although the effect size seems to be somewhat smaller than what has been reported in civilian PTSD studies. Adequately powered studies are needed to confirm these results and to assess whether continued treatment maintains or further improves response.
authors.affiliation: Division of Psychiatry, Chaim-Sheba Medical Center, Tel-Hashomer, Ramat Gan, Israel. jzohar@post.tau.ac.il
authors.forename: Joseph
authors.initials: J
authors.lastname: Zohar
authors.forename: Daniela
authors.initials: D
authors.lastname: Amital
authors.forename: Chanoch
authors.initials: C
authors.lastname: Miodownik
authors.forename: Moshe
authors.initials: M
authors.lastname: Kotler
authors.forename: Avi
authors.initials: A
authors.lastname: Bleich
authors.forename: Roger M
authors.initials: RM
authors.lastname: Lane
authors.forename: Carol
authors.initials: C
authors.lastname: Austin
mesh_terms: D000328:Adult; D000553:Ambulatory Care; D000928:Antidepressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D003130:Combat Disorders / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007557:Israel; D008297:Male; D008875:Middle Aged; D010555:Personality Inventory; D010865:Pilot Projects; D020280:Sertraline / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D014728:Veterans / Q000523:psychology*
chemical_list: D000928:Antidepressive Agents; D020280:Sertraline