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A Flexible-Dose Multicenter Trial

Mark H. Pollack, MD; Michael W. Otto, PhD; John J. Worthington, MD; Gisele Gus Manfro, MD; Robert Wolkow, MD

Arch Gen Psychiatry. 1998;55:1010-1016.

Background  The serotonin selective reuptake inhibitors are increasingly being used for the treatment of panic disorder. We examined the efficacy and safety of the serotonin selective reuptake inhibitor sertraline hydrochloride in patients with panic disorder.

Methods  One hundred seventy-six nondepressed outpatients with panic disorder, with or without agoraphobia, from 10 sites followed identical protocols that used a flexible-dose design. After 2 weeks of single-blind placebo, patients were randomly assigned to 10 weeks of double-blind, flexible-dose treatment with either sertraline hydrochloride (50-200 mg/d) or placebo.

Results  Sertraline-treated patients exhibited significantly greater improvement (P=.01) at end point than did patients treated with placebo for the primary outcome variable, panic attack frequency. Significant differences between groups were also evident for clinician and patient assessments of improvement as measured by the Clinical Global Impression Improvement (P=.01) and Severity (P=.009) Scales, Panic Disorder Severity Scale ratings (P=.03), high end-state function assessment (P=.03), Patient Global Evaluation rating (P=.01), and quality of life scores (P=.003). Adverse events, generally characterized as either mild or moderate, were not significantly different in overall incidence between the sertraline and placebo groups.

Conclusion  Results support the safety and efficacy of sertraline for the short-term treatment of patients with panic disorder.

From the Anxiety Disorders Program, Department of Psychiatry, Massachusetts General Hospital, Boston (Drs Pollack, Otto, and Worthington); Department of Psychiatry, Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil (Dr Manfro); and Clinical and Scientific Affairs, Pfizer Pharmaceuticals Inc, New York, NY (Dr Wolkow).

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