SERTRALINE IN THE TREATMENT OF PANIC DISORDER - A FLEXIBLE-DOSE MULTICENTER TRIAL

Background: The serotonin selective reuptake inhibitors are increasing ly being used for the treatment of panic disorder. We examined the eff icacy and safety of the serotonin selective reuptake inhibitor sertral ine hydrochloride in patients with panic disorder. Methods: One hundre d seventy-six nondepressed outpatients with panic disorder, with or wi thout agorapho bia, from 10 sites followed identical protocols that us ed a flexible-dose design. After 2 weeks of single-blind placebo, pati ents were randomly assigned to 10 weeks of double-blind, flexible-dose treatment with either sertraline hydrochloride (50-200 mg/d) or place bo. Results: Sertraline-treated patients exhibited significantly great er improvement (P = .01) at end point than did patients treated with p lacebo for the primary outcome variable, panic attack frequency. Signi ficant 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 as sessment (P = .03), Patient Global Evaluation rating (P = .01), and qu ality of life scores (P = .003). Adverse events, generally characteriz ed as either mild or moderate, were not significantly different in ove rall incidence between the sertraline and placebo groups. Conclusion: Results support the safety and efficacy of sertraline for the short-te rm treatment of patients with panic disorder.