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.

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 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.

THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

Selective Serotonin Reuptake Inhibitors for Premenstrual Syndrome and Premenstrual Dysphoric Disorder: A Meta-Analysis
Shah et al.
Obstet Gynecol 2008;111:1175-1182.
ABSTRACT | FULL TEXT  

Efficacy of a New Low-Dose Oral Contraceptive With Drospirenone in Premenstrual Dysphoric Disorder
Yonkers et al.
Obstet Gynecol 2005;106:492-501.
ABSTRACT | FULL TEXT  

Quality-of-Life Impairment in Depressive and Anxiety Disorders
Rapaport et al.
Am. J. Psychiatry 2005;162:1171-1178.
ABSTRACT | FULL TEXT  

Premenstrual Syndrome, Premenstrual Dysphoric Disorder, and Beyond: A Clinical Primer for Practitioners
Johnson
Obstet Gynecol 2004;104:845-859.
ABSTRACT | FULL TEXT  

Paroxetine Controlled Release for Premenstrual Dysphoric Disorder: A Double-Blind, Placebo-Controlled Trial
Cohen et al.
Psychosom. Med. 2004;66:707-713.
ABSTRACT | FULL TEXT  

Continuous or Intermittent Dosing With Sertraline for Patients With Severe Premenstrual Syndrome or Premenstrual Dysphoric Disorder
Freeman et al.
Am. J. Psychiatry 2004;161:343-351.
ABSTRACT | FULL TEXT  

Premenstrual Dysphoric Disorder
Grady-Weliky
NEJM 2003;348:433-438.
FULL TEXT  

Efficacy of Intermittent, Luteal Phase Sertraline Treatment of Premenstrual Dysphoric Disorder
Halbreich et al.
Obstet Gynecol 2002;100:1219-1229.
ABSTRACT | FULL TEXT  

SSRIs for premenstrual dysphoric disorder
DTB 2002;40:70-72.
ABSTRACT | FULL TEXT  

Premenstrual Daily Fluoxetine for Premenstrual Dysphoric Disorder: A Placebo-Controlled, Clinical Trial Using Computerized Diaries
Cohen et al.
Obstet Gynecol 2002;100:435-444.
ABSTRACT | FULL TEXT  

Severity of Premenstrual Symptoms in a Health Maintenance Organization Population
Sternfeld et al.
Obstet Gynecol 2002;99:1014-1024.
ABSTRACT | FULL TEXT  

Venlafaxine in the Treatment of Premenstrual Dysphoric Disorder
Freeman et al.
Obstet Gynecol 2001;98:737-744.
ABSTRACT | FULL TEXT  

Differential Response to Antidepressants in Women With Premenstrual Syndrome/Premenstrual Dysphoric Disorder: A Randomized Controlled Trial
Freeman et al.
Arch Gen Psychiatry 1999;56:932-939.
ABSTRACT | FULL TEXT  

Characteristics of Placebo Responses in Medical Treatment of Premenstrual Syndrome
Freeman and Rickels
Am. J. Psychiatry 1999;156:1403-1408.
ABSTRACT | FULL TEXT  

Iatrogenic Acute Estrogen Deficiency and Psychiatric Syndromes in Breast Cancer Patients
Duffy et al.
Psychosomatics 1999;40:304-308.
ABSTRACT | FULL TEXT  

Luteal Phase Sertraline Treatment for Premenstrual Dysphoric Disorder: Results of a Double-blind, Placebo-Controlled, Crossover Study
Jermain et al.
Arch Fam Med 1999;8:328-332.
ABSTRACT | FULL TEXT  

A 45-Year-Old Woman With Premenstrual Dysphoric Disorder
Parry
JAMA 1999;281:368-373.
FULL TEXT  

Longitudinal Population-Based Twin Study of Retrospectively Reported Premenstrual Symptoms and Lifetime Major Depression
Kendler et al.
Am. J. Psychiatry 1998;155:1234-1240.
ABSTRACT | FULL TEXT  

Use of Serotonin Reuptake Inhibitors by Women of Childbearing Potential
Goldstein et al.
JAMA 1998;279:1873-1874.
FULL TEXT  

Other articles noted
Evid. Based Ment. Health 1998;1:36-36.
FULL TEXT  

Sertraline for Premenstrual Dysphoric Disorder
Cohen et al.
JAMA 1998;279:357-358.
FULL TEXT  

Selective serotonin reuptake inhibitors in affective disorders -II. Efficacy and quality of life
Goodnick and Goldstein
J Psychopharmacol 1998;12:S21-S54.
ABSTRACT  

Sertraline for PMDD
JWatch Psychiatry 1997;1997:9-9.
FULL TEXT  

Sertraline: Relief for PMS?
JWatch Women's Health 1997;1997:18-18.
FULL TEXT  

SERTRALINE FOR PREMENSTRUAL DYSPHORIC DISORDER
JWatch General 1997;1997:6-6.
FULL TEXT