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Non-randomised trial, 1996

Does fluvoxamine help premenstrual dysphoric disorder?

In this open-label study, fluvoxamine at 100 mg per day improved PMDD symptoms in 60% of women, with the biggest improvements in irritability, anxiety, and feeling out of control. Side effects were mostly mild and temporary.

Early or limited evidence 10 women with PMDD (12 initially screened)

What they did

Researchers conducted an open-label trial where women took fluvoxamine (an antidepressant medication) daily for 2 menstrual cycles. The dose was gradually increased to 100 mg per day. Women tracked their symptoms daily.

What they found

At 4 weeks, mean premenstrual symptom scores improved significantly, and improvement continued at 8 weeks. The biggest improvements were in irritability, anxiety, feeling out of control, and decreased interest in activities. 60% (6 of 10) of women had at least 50% reduction in symptoms. Side effects included insomnia (6 women), fatigue (4), dry mouth (4), and nausea (3), and were generally mild and temporary.

What it means for you

Fluvoxamine may help PMDD symptoms, with most benefits for mood and anxiety. This is an open-label pilot study with only 10 women and no control group, so we cannot be certain of the effect without a larger controlled trial. The side effects were generally mild.

10

Women completing treatment

60%

With 50% or greater symptom improvement

100 mg/day

Final dose

About the study

Original title
Fluvoxamine for premenstrual dysphoric disorder: a pilot study
Authors
Freeman EW, Rickels K, Sondheimer SJ
Journal
The Journal of clinical psychiatry
Year
1996
Study design
Non-randomised trial
Participants
6
What was tested
Fluvoxamine (antidepressant) at 85-100 mg per day for 2 menstrual cycles

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