A placebo-controlled, randomized withdrawal study of sertraline for panic disorder in Japan

Kunitoshi Kamijima, Tomifusa Kuboki, Hiroaki Kumano, Tal Burt, Guy Cohen, Ichiro Arano, Toshimitsu Hamasaki

Research output: Contribution to journalArticle

18 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)265-273
Number of pages9
JournalInternational Clinical Psychopharmacology
Volume20
Issue number5
DOIs
Publication statusPublished - 2005 Sep 1

Keywords

  • Japan
  • Panic disorder
  • Sertraline

ASJC Scopus subject areas

  • Psychiatry and Mental health
  • Pharmacology (medical)

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