COMPARISON OF FLUVOXAMINE, IMIPRAMINE, AND PLACEBO IN THE TREATMENT OF OUTPATIENTS WITH PANIC DISORDER

Fluvoxamine and imipramine were compared to placebo in an 8-week doubl e-blind randomized multicentre trial comprising of 148 outpatients bet ween 19 and 57 years of age (mean: 35) with a DSM-III-R diagnosis of P anic Disorder. Mean daily dose at endpoint was: fluvoxamine, 171.4 mg; imipramine 164.7 mg. The mean number of panic attacks per week at bas eline were 10.9, 14.4 and 6.5 for fluvoxamine, imipramine and placebo, respectively. The intent-to-treat analysis of the change from baselin e (difference score) of the number of panic attacks at endpoint reveal ed: a difference of 3.3 attacks (95% CI: -0.3, 6.8) between fluvoxamin e and placebo and a difference of 6.0 attacks (95% CI: 1.5, 10.5) betw een imipramine and placebo. Treatment was stopped prematurely in 31 (6 2%) on fluvoxamine, 16 (33%) on imipramine and 29 (58%) on placebo. Th e number of patients withdrawing due to intolerance was 13 (26%) for f luvoxamine, 10 (21%) for imipramine and 4 (8%) for placebo. The number of patients withdrawing due to lack of efficacy was 10 (20%) for fluv oxamine, 4 (8%) for imipramine and 12 (24%) for placebo. Overall, this study demonstrated that fluvoxamine was not effective in the treatmen t of panic disorder but did show a strong effect for imipramine. A cha nce occurrence of significantly fewer number of panic attacks in the p lacebo group at baseline may limit the conclusions of this study. (C) 1996 Wiley-Liss, Inc.