Sertraline Helpful in Premenstrual Dysphoric Disorder

Laurie Barclay, MD

December 09, 2002

Dec. 9, 2002 — Intermittent sertraline was found to be effective for treatment of premenstrual dysphoric disorder (PMDD) in a randomized double-blind trial reported in the December issue of Obstetrics & Gynecology.

"Intermittent luteal phase treatment with sertraline, in doses of 50-100 mg daily, is a highly effective treatment strategy for managing patients suffering from PMDD of moderate or greater severity," write Uriel Halbreich, MD, from the State University of New York at Buffalo, and colleagues.

In this study, 281 women meeting DSM-4 criteria for PMDD completed two prospective screening cycles and one single-blind placebo cycle, followed by three cycles of double-blind, luteal phase treatment with either placebo or sertraline in a flexible daily dose of 50 to 100 mg.

Compared with placebo, sertraline was superior in terms of Clinical Global Impression Improvement scale score (2.7 ± 1.1 vs. 2.3 ± 1.1; P < .001), Daily Record of Severity of Problems change scores (17.6 ± 23.3 vs. 27.6 ± 26.8; P < .002), and quality of life and functioning outcomes. Responder rates, defined as percentage of patients with Clinical Global Impression Improvement scale score of 1 or 2 by cycle 1, were 50% for sertraline and 26% for placebo (P < .001).

Study discontinuation because of adverse events occurred in 8% of patients receiving sertraline and in less than 1% receiving placebo. Study limitations that limit generalizability of the findings include exclusion of patients with comorbid anxiety or affective disorders; the high educational level, motivation, and compliance of the subjects; and very mild depressive symptoms during the midfollicular phase, which often respond well to placebo.

Sertraline "effectively improved not only PMDD symptoms, but also quality of life, functional, and social adjustment measures," the authors write. "It appears to provide an appealing treatment option for a disorder that is both intermittent-episodic and chronic."

Pfizer, Inc., funded this study.

Obstet Gynecol. 2002;100:1219-1229

Reviewed by Gary D. Vogin, MD

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