title: A placebo-controlled, randomized withdrawal study of sertraline for panic disorder in Japan.
abstract: The objective of this double-blind, placebo-controlled randomized withdrawal study was to evaluate the efficacy and safety of sertraline for 8 weeks in treating Japanese patients with DSM-IV panic disorder. Patients (n=394) were initially treated with 8 weeks of open-label sertraline followed by 8 weeks of double-blind treatment with either sertraline (50-100 mg/day) or placebo. Responders during the open-label phase were eligible to be entered into the double-blind phase. Two hundred and forty patients were entered to the double-blind phase and randomly assigned to receive sertraline (n=119) or placebo (n=121). On the primary efficacy measure (relapse), there was no significant difference between the two treatment groups (sertraline 10.1%; placebo 13.2%). However, the frequency of panic attacks was significantly (P=0.012) lower for sertraline compared to placebo. The proportion of sertraline-treated patients who met response criteria (Clinical Global Impression-Improvement Scale score of 1 or 2) at the end of double-blind phase treatment was also significantly (P=0.003) higher for sertraline (89.9%) compared to placebo (74.4%). Panic Disorder Severity Scale total score was significantly (P=0.012) lower in the sertraline group compared to the placebo group. Adverse events during acute treatment were consistent with the known adverse event profile of sertraline, and the incidence of adverse events during the double-blind phase treatment was not different between sertraline and placebo.
authors.affiliation: Department of Psychiatry, Showa University School of Medicine, 1-5-8 Hatanodai, Shinagawa, Tokyo, Japan. kamijima@med.showa-u.ac.jp
authors.forename: Kunitoshi
authors.initials: K
authors.lastname: Kamijima
authors.forename: Tomifusa
authors.initials: T
authors.lastname: Kuboki
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Kumano
authors.forename: Tal
authors.initials: T
authors.lastname: Burt
authors.forename: Guy
authors.initials: G
authors.lastname: Cohen
authors.forename: Ichiro
authors.initials: I
authors.lastname: Arano
authors.forename: Toshimitsu
authors.initials: T
authors.lastname: Hamasaki
mesh_terms: D000328:Adult; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D016584:Panic Disorder / Q000209:etiology*; D010919:Placebos; D011569:Psychiatric Status Rating Scales; D017367:Selective Serotonin Reuptake Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D020280:Sertraline / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012720:Severity of Illness Index
chemical_list: D010919:Placebos; D017367:Selective Serotonin Reuptake Inhibitors; D020280:Sertraline