Randomised trial, 1997
Does sertraline reduce PMDD symptoms and improve women's ability to function?
Yes, sertraline significantly reduced symptoms and improved functioning. 62% of the sertraline group had much or very much improvement compared to 34% of the placebo group.
What they did
A large randomized double-blind trial at 12 university-affiliated sites. 447 women applied; 243 with confirmed PMDD were randomized; 200 completed the study. Women took placebo for one cycle, then either sertraline (flexible dose 50-150 mg) or placebo for 3 cycles.
What they found
Average symptom scores decreased from 64 to 44 with sertraline, compared to 62 to 54 with placebo. All symptom clusters improved with sertraline (depressed mood, physical symptoms, anger and irritability). Depression scale scores dropped 44% with sertraline versus 29% with placebo. 62% of the sertraline group had much or very much improvement compared to 34% of the placebo group. Women's functional impairment at baseline was substantial and improved more with sertraline.
What it means for you
Sertraline is a proven, effective treatment for PMDD that reduces both symptoms and their impact on daily life and work. It was tested in a large, well-designed study. The study was conducted at university clinics, so results may vary in other settings.
62%
Much/very much improvement with sertraline
34%
Much/very much improvement with placebo
243
Women randomized
About the study
- Original title
- Symptomatic improvement of premenstrual dysphoric disorder with sertraline treatment. A randomized controlled trial. Sertraline Premenstrual Dysphoric Collaborative Study Group
- Authors
- Yonkers KA, Halbreich U, Freeman E et al.
- Journal
- JAMA
- Year
- 1997
- Study design
- Randomised trial
- Participants
- 447
- What was tested
- Sertraline 50-150 mg daily (flexible dose) versus placebo
- Read the paper
- doi.org/10.1001/jama.1997.03550120043031
Topics
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