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Reboxetine, a Selective Norepinephrine Reuptake Inhibitor, Is an Effective and Well-Tolerated Treatment for Panic Disorder
Marcio Versiani, M.D.; Giovanni Cassano, M.D.; Giulio Perugi, M.D.; Alessandra Benedetti, M.D.; Luigia Mastalli, M.D.; Antonio Nardi, M.D.; and Mario Savino, M.D.
Background: Tricyclic antidepressants and selective serotonin reuptake inhibitors (SSRIs) as well as benzodiazepines have been shown to be effective for the treatment of panic disorder. The introduction of SSRIs has enabled a greater understanding of the role of serotonin in the etiology of panic disorder; however, the role of norepinephrine has been more challenging to ascertain. The aim of this study was to determine the efficacy and tolerability of reboxetine, a novel selective norepinephrine reuptake inhibitor, in patients with panic disorder with and without agoraphobia.
Method: Eighty-two patients (aged 18-65 years) with DSM-III-R panic disorder, with or without agoraphobia, were randomly assigned to receive 6 to 8 mg/day of reboxetine (42 patients) or placebo (40 patients) for 8 weeks in this placebo-controlled, parallel-group, double-blind clinical trial.
Results: Of the 82 patients enrolled in the trial, 75 were considered in the analysis (37 patients in the reboxetine group and 38 patients in the placebo group). At last assessment, there was a significant reduction in the mean number of panic attacks (range, 9.3-1.2) and phobic symptoms (range, 8.1-3.2) in the reboxetine group compared with the placebo group (ranges, 8.5-5.8 and 7.7-5.2, respectively; p<.05). Improvement in Hamilton Rating Scale for Depression, Hopkins Symptom Checklist-90, and Sheehan Disability Scale scores were also greater in the reboxetine group compared with the placebo group. Adverse events reported more frequently with reboxetine than placebo included dry mouth (36% vs. 16%), constipation (27% vs. 22%), and insomnia (26% vs. 22%).
Conclusion: Reboxetine was effective and well tolerated in the treatment of panic disorder.
(J Clin Psychiatry 2002;63:31-37)
Received May 1, 2001; accepted Oct. 18, 2001. From the Institute of Psychiatry, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil (Drs. Versiani and Nardi); and the Department of Psychiatry, University of Pisa, Pisa, Italy (Drs. Cassano, Perugi, Benedetti, Mastalli, and Savino).
Supported by Pharmacia Corporation.
Reprint requests to: Professor M. Versiani, Institute of Psychiatry, Federal University of Rio de Janeiro, Rua Visconde de Pirajá 407 s 805, Rio de Janeiro 22410-003, Brazil.