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Luteal Phase Sertraline Treatment for Premenstrual Dysphoric Disorder
Results of a Double-blind, Placebo-Controlled, Crossover Study
Donna M. Jermain, PharmD, BCPP;
Cheryl K. Preece, MS;
Robin L. Sykes, CCRA;
Thomas J. Kuehl, PhD;
Patricia J. Sulak, MD
Arch Fam Med. 1999;8:328-332.
Objective 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.
Design 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.
Setting A large outpatient multispecialty clinic in central Texas.
Patients Fifty-seven women aged 19 to 49 years with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, diagnosis of premenstrual dysphoric disorder.
Interventions Late-luteal phase treatment with sertraline hydrochloride in daily doses of 50 mg (cycle 1) followed by 100 mg (cycle 2) vs placebo.
Main Outcome Measures 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.
Results 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.
Conclusions 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.
From the Department of Pharmacy (Dr Jermain), the Women's Healthcare Research Program (Ms Sykes and Dr Sulak), the Division of Ambulatory Care, Department of Obstetrics and Gynecology (Dr Sulak), and the Departments of Obstetrics and Gynecology, Pathology, Medical Biochemistry, Genetics (Dr Kuehl), and Biostatistics (Ms Preece), Scott & White Memorial Hospital, Temple, Tex; the Departments of Medicine and Psychiatry (Dr Jermain) and the College of Medicine (Drs Kuehl and Sulak), Texas A&M University Health Science Center, Temple, Tex; and the College of Pharmacy, University of Texas at Austin (Dr Jermain).
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