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September 24, 1997

Symptomatic Improvement of Premenstrual Dysphoric Disorder With Sertraline TreatmentA Randomized Controlled Trial

Author Affiliations

for the Sertraline Premenstrual Dysphoric Collaborative Study Group
From the Departments of Psychiatry and Obstetrics and Gynecology, The University of Texas Southwestern Medical Center at Dallas (Dr Yonkers), University of Buffalo, Buffalo, NY (Dr Halbreich), and University of Pennsylvania, Philadelphia (Dr Freeman); Departments of Clinical Pharmacy and Psychiatry, University of Tennessee, Memphis (Dr Brown); Department of Research Assessment and Training, New York State Psychiatric Institute, New York (Dr Endicott); Departments of Psychiatry, Western Psychiatric Institute, Pittsburgh, Pa (Dr Frank), University of California, San Diego (Dr Parry), Brown University, Providence, RI (Dr Pearlstein), University of New Mexico Health Science Center, Albuquerque (Dr Severino), Duke University, Durham, NC (Dr Stout), and University of Massachusetts Medical Center, Worcester (Dr Stone); and Pfizer Inc, New York, NY (Dr Harrison).

JAMA. 1997;278(12):983-988. doi:10.1001/jama.1997.03550120043031

Context.  —Premenstrual dysphoric disorder is an important cause of symptoms and functional impairment in menstruating women.

Objective.  —To evaluate the efficacy of sertraline hydrochloride for treatment of premenstrual dysphoria by measuring changes in symptom expression and functional impairment.

Design.  —Two screening cycles followed by 1 single-blind placebo cycle and 3 cycles of randomized, double-blind, placebo treatment.

Setting.  —Twelve university-affiliated outpatient psychiatry and gynecology clinics.

Patients.  —Of the 447 women who requested participation, 243 met criteria for premenstrual dysphoric disorder and were randomized; 200 women completed the study.

Intervention.  —A flexible (50-150 mg) daily dose of sertraline hydrochloride.

Main Outcome Measures.  —The Daily Record of Severity of Problems, Hamilton Rating Scale for Depression, Clinical Global Impression Scale, and Social Adjustment Scale.

Results.  —Mean (±SD) total daily symptom scores decreased significantly (P<.001) in the sertraline-treated (64±22 to 44±19) compared with the placebotreated (62±22 to 54±24) groups. Significant improvement (P<.05) was found for all clinically derived symptom clusters (depressive, physical, and anger/irritability symptoms). Hamilton Rating Scale for Depression scores decreased by 44% and 29% in the sertraline and placebo groups, respectively (P<.002). End-point global ratings showed much or very much improvement in 62% of the active treatment group and 34% of the placebo treatment group (P<.001). Reported functional impairment was substantial at baseline. Improvement in psychosocial functioning with treatment was similar to what is found in studies of major depression.

Conclusions.  —Sertraline was significantly better than placebo for treatment of premenstrual dysphoria as reflected by symptomatic improvement and change in reported functional impairment. Serotonin reuptake inhibitors such as sertraline are useful therapeutic options for women with premenstrual dysphoria.