• JAMA · Sep 1997

    Randomized Controlled Trial Multicenter Study Clinical Trial

    Symptomatic improvement of premenstrual dysphoric disorder with sertraline treatment. A randomized controlled trial. Sertraline Premenstrual Dysphoric Collaborative Study Group.

    • K A Yonkers, U Halbreich, E Freeman, C Brown, J Endicott, E Frank, B Parry, T Pearlstein, S Severino, A Stout, A Stone, and W Harrison.
    • Department of Psychiatry, The University of Texas Southwestern Medical Center at Dallas, 75235, USA.
    • JAMA. 1997 Sep 24; 278 (12): 983988983-8.

    ContextPremenstrual dysphoric disorder is an important cause of symptoms and functional impairment in menstruating women.ObjectiveTo evaluate the efficacy of sertraline hydrochloride for treatment of premenstrual dysphoria by measuring changes in symptom expression and functional impairment.DesignTwo screening cycles followed by 1 single-blind placebo cycle and 3 cycles of randomized, double-blind, placebo treatment.SettingTwelve university-affiliated outpatient psychiatry and gynecology clinics.PatientsOf the 447 women who requested participation, 243 met criteria for premenstrual dysphoric disorder and were randomized; 200 women completed the study.InterventionA flexible (50-150 mg) daily dose of sertraline hydrochloride.Main Outcome MeasuresThe Daily Record of Severity of Problems, Hamilton Rating Scale for Depression, Clinical Global Impression Scale, and Social Adjustment Scale.ResultsMean (+/-SD) total daily symptom scores decreased significantly (P<.001) in the sertraline-treated (64+/-22 to 44+/-19) compared with the placebo-treated (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.ConclusionsSertraline 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.

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