Symptomatic improvement of premenstrual dysphoric disorder with sertraline treatment

A randomized controlled trial

Kimberly A. Yonkers, Uriel Halbreich, Ellen Freeman, Candace Brown, Jean Endicott, Ellen Frank, Barbara Parry, Teri Pearlstein, Sally Severino, Anna Stout, Andrea Stone, Wilma Harrison

Research output: Contribution to journalArticle

251 Citations (Scopus)

Abstract

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 t 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 woman 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<.00l) 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.

Original languageEnglish (US)
Pages (from-to)983-988
Number of pages6
JournalJournal of the American Medical Association
Volume278
Issue number12
StatePublished - Sep 24 1997

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Sertraline
Randomized Controlled Trials
Placebos
Depression
Therapeutics
Social Adjustment
Anger
Serotonin Uptake Inhibitors
Premenstrual Dysphoric Disorder
Gynecology
Psychiatry
Outpatients
Outcome Assessment (Health Care)

All Science Journal Classification (ASJC) codes

  • Medicine(all)

Cite this

Yonkers, K. A., Halbreich, U., Freeman, E., Brown, C., Endicott, J., Frank, E., ... Harrison, W. (1997). Symptomatic improvement of premenstrual dysphoric disorder with sertraline treatment: A randomized controlled trial. Journal of the American Medical Association, 278(12), 983-988.

Symptomatic improvement of premenstrual dysphoric disorder with sertraline treatment : A randomized controlled trial. / Yonkers, Kimberly A.; Halbreich, Uriel; Freeman, Ellen; Brown, Candace; Endicott, Jean; Frank, Ellen; Parry, Barbara; Pearlstein, Teri; Severino, Sally; Stout, Anna; Stone, Andrea; Harrison, Wilma.

In: Journal of the American Medical Association, Vol. 278, No. 12, 24.09.1997, p. 983-988.

Research output: Contribution to journalArticle

Yonkers, KA, Halbreich, U, Freeman, E, Brown, C, Endicott, J, Frank, E, Parry, B, Pearlstein, T, Severino, S, Stout, A, Stone, A & Harrison, W 1997, 'Symptomatic improvement of premenstrual dysphoric disorder with sertraline treatment: A randomized controlled trial', Journal of the American Medical Association, vol. 278, no. 12, pp. 983-988.
Yonkers, Kimberly A. ; Halbreich, Uriel ; Freeman, Ellen ; Brown, Candace ; Endicott, Jean ; Frank, Ellen ; Parry, Barbara ; Pearlstein, Teri ; Severino, Sally ; Stout, Anna ; Stone, Andrea ; Harrison, Wilma. / Symptomatic improvement of premenstrual dysphoric disorder with sertraline treatment : A randomized controlled trial. In: Journal of the American Medical Association. 1997 ; Vol. 278, No. 12. pp. 983-988.
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abstract = "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 t 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 woman 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<.00l) 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.",
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AU - Yonkers, Kimberly A.

AU - Halbreich, Uriel

AU - Freeman, Ellen

AU - Brown, Candace

AU - Endicott, Jean

AU - Frank, Ellen

AU - Parry, Barbara

AU - Pearlstein, Teri

AU - Severino, Sally

AU - Stout, Anna

AU - Stone, Andrea

AU - Harrison, Wilma

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N2 - 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 t 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 woman 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<.00l) 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.

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