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Symptomatic improvement of premenstrual dysphoric disorder with sertraline treatment. A randomized controlled trial. Sertraline Premenstrual Dysphoric Collaborative Study Group. 1997

K A Yonkers, and U Halbreich, and E Freeman, and C Brown, and J Endicott, and E Frank, and B Parry, and T Pearlstein, and S Severino, and A Stout, and A Stone, and W Harrison
Department of Psychiatry, The University of Texas Southwestern Medical Center at Dallas, 75235, USA.

BACKGROUND 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. METHODS Two screening cycles followed by 1 single-blind placebo cycle and 3 cycles of randomized, double-blind, placebo treatment. METHODS Twelve university-affiliated outpatient psychiatry and gynecology clinics. METHODS Of the 447 women who requested participation, 243 met criteria for premenstrual dysphoric disorder and were randomized; 200 women completed the study. METHODS A flexible (50-150 mg) daily dose of sertraline hydrochloride. METHODS 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 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. 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.

UI MeSH Term Description Entries
D007508 Irritable Mood Abnormal or excessive excitability with easily triggered anger, annoyance, or impatience. Mood, Irritable,Irritable Moods,Moods, Irritable
D008183 Luteal Phase The period in the MENSTRUAL CYCLE that follows OVULATION, characterized by the development of CORPUS LUTEUM, increase in PROGESTERONE production by the OVARY and secretion by the glandular epithelium of the ENDOMETRIUM. The luteal phase begins with ovulation and ends with the onset of MENSTRUATION. Menstrual Cycle, Luteal Phase,Menstrual Cycle, Secretory Phase,Menstrual Secretory Phase,Postovulatory Phase,Phase, Luteal,Phase, Postovulatory,Secretory Phase, Menstrual
D011293 Premenstrual Syndrome A combination of distressing physical, psychologic, or behavioral changes that occur during the luteal phase of the menstrual cycle. Symptoms of PMS are diverse (such as pain, water-retention, anxiety, cravings, and depression) and they diminish markedly 2 or 3 days after the initiation of menses. Premenstrual Tension,Premenstrual Syndromes,Premenstrual Tensions,Syndrome, Premenstrual,Syndromes, Premenstrual,Tension, Premenstrual,Tensions, Premenstrual
D003863 Depression Depressive states usually of moderate intensity in contrast with MAJOR DEPRESSIVE DISORDER present in neurotic and psychotic disorders. Depressive Symptoms,Emotional Depression,Depression, Emotional,Depressive Symptom,Symptom, Depressive
D004311 Double-Blind Method A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment. Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D004526 Efficiency Ratio of output to effort and or resources, or the ratio of effort and or resources produced to energy expended. Productivity
D005260 Female Females
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000328 Adult A person having attained full growth or maturity. Adults are of 19 through 44 years of age. For a person between 19 and 24 years of age, YOUNG ADULT is available. Adults
D000704 Analysis of Variance A statistical technique that isolates and assesses the contributions of categorical independent variables to variation in the mean of a continuous dependent variable. ANOVA,Analysis, Variance,Variance Analysis,Analyses, Variance,Variance Analyses

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