Luteal phase sertraline treatment for premenstrual dysphoric disorder. Results of a double-blind, placebo-controlled, crossover study

• Published in: Archives of family medicine Vol. 8; no. 4; pp. 328 - 332
• Main Authors: Jermain, D M, Preece, C K, Sykes, R L, Kuehl, T J, Sulak, P J
• Format: Magazine Article
• Language: English
• Published: United States 01-07-1999
• Subjects: Adult; Antidepressive Agents - therapeutic use; Cross-Over Studies; Double-Blind Method; Female; Humans; Luteal Phase; Middle Aged; Premenstrual Syndrome - drug therapy; Premenstrual Syndrome - psychology; Serotonin Uptake Inhibitors - therapeutic use; Sertraline - therapeutic use; Severity of Illness Index; Treatment Outcome
• ISSN: 1063-3987
• DOI: 10.1001/archfami.8.4.328

To test the efficacy of late-luteal phase dosing of sertraline hydrochloride in women with moderate-to-severe premenstrual dysphoric disorder. This highly prevalent disorder often causes significant psychosocial impairment.
Double-blind, crossover trial of each 2-menstrual cycle of baseline, sertraline treatment, and placebo. Randomization to sertraline treatment vs placebo occurred after a 2-cycle, drug-free period.
A large outpatient multispecialty clinic in central Texas.
Fifty-seven women aged 19 to 49 years with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, diagnosis of premenstrual dysphoric disorder.
Late-luteal phase treatment with sertraline hydrochloride in daily doses of 50 mg (cycle 1) followed by 100 mg (cycle 2) vs placebo.
The 22-item calendar of premenstrual experiences was completed daily and constituted the primary outcome measure, consisting of a total score and behavioral and physical factor scores.
A repeated-measures analysis of variance for crossover designs found a significant beneficial effect from sertraline treatment in improving the calendar of premenstrual experiences total (P < .01), behavioral factor (P < .01), and physical factor (P < .04) scores. Most women improved when taking sertraline, 50 mg, although a dose increase to 100 mg yielded further improvement in approximately 25% of women. Use of sertraline was extremely well tolerated; the only adverse event reported by 10% or more of women was insomnia in 8 (14%) of them.
Luteal phase treatment with sertraline was a safe and effective treatment for moderate-to-severe premenstrual dysphoric disorder. Further controlled studies are needed to confirm the results of this preliminary study.