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Low-Dose Sertraline in the Treatment of Moderate-to-Severe Premenstrual Syndrome: Efficacy of 3 Dosing Strategies

Susan G. Kornstein, M.D.; Teri B. Pearlstein, M.D.; Rana Fayyad, Ph.D.; Gail M. Farfel, Ph.D.; and John A. Gillespie, M.D.

Objective: Many studies have demonstrated the efficacy of selective serotonin reuptake inhibitors (SSRIs) in the treatment of premenstrual dysphoric disorder, but few studies have investigated the efficacy of SSRIs in the treatment of premenstrual syndrome (PMS). The objective of this study was to evaluate the safety and efficacy of sertraline in the treatment of moderate-to-severe PMS using 3 different dosing strategies: luteal phase (2 cycles), followed by continuous dosing throughout the month (1 cycle), followed by dosing begun at the first onset of PMS symptoms, or "symptom-onset" dosing (1 cycle).

Method: 314 women with PMS from 22 U.S. sites were randomly assigned to fixed-dose treatment with sertraline (25 or 50 mg/day) or placebo for 4 menstrual cycles after a single-blind, placebo lead-in cycle. Assessments included the Daily Symptom Report (DSR), the Clinical Global Impressions-Severity of Illness and -Improvement scales, the Patient Global Evaluation scale, the Quality of Life Enjoyment and Satisfaction Questionnaire, and the Social Adjustment Scale-Self Report.

Results: Intermittent luteal-phase dosing with low doses of sertraline (25 and 50 mg/day) produced significant improvement across 2 menstrual cycles, based on total DSR scores, compared with placebo. Continuous and symptom-onset dosing were also effective in treating PMS symptoms, particularly at the lower dose of 25 mg/day.

Conclusions: The results of the current study suggest that low doses of sertraline may be a safe, effective, and well-tolerated treatment for moderate-to-severe PMS.

(J Clin Psychiatry 2006;67:1624-1632)

Received Oct. 20, 2005; accepted June 26, 2006. From the Virginia Commonwealth University School of Medicine, Richmond, Va. (Dr. Kornstein); the Brown University School of Medicine, Providence, R.I. (Dr. Pearlstein); and Pfizer, Inc., New York, N.Y. (Drs. Fayyad, Farfel, and Gillespie).

Study funded by Pfizer, Inc.

Dr. Kornstein has received grant/research support from Pfizer, Bristol-Myers Squibb, Eli Lilly, Forest, GlaxoSmithKline, Merck, Biovail, Wyeth, Berlex, Novartis, Sepracor, Boehringer-Ingelheim, and Sanofi-Synthelabo; is a consultant to or has received honoraria from Pfizer, Bristol-Myers Squibb, Eli Lilly, Wyeth, and Berlex; and serves on advisory boards of Pfizer, Wyeth, Eli Lilly, Bristol-Myers Squibb, Warner-Chilcott, and Biovail. Drs. Fayyad, Farfel, and Gillespie are employees of and major stock shareholders in Pfizer, Inc. Dr. Pearlstein reports no additional financial or other relationships relevant to the subject of this article.

Acknowledgments appear at the end of this article.

Corresponding author and reprints: Susan G. Kornstein, M.D., Department of Psychiatry, Virginia Commonwealth University, P.O. Box 980710, Richmond, VA 23298-0710 (e-mail: