Randomised trial, 2004
Does the antidepressant paroxetine CR reduce PMDD mood symptoms?
Yes. In this large trial, both a lower and a higher dose of paroxetine CR significantly improved mood symptoms compared with placebo, with the higher dose working somewhat better.
What they did
A multicenter, placebo-controlled, double-blind trial at 43 U.S. outpatient sites randomly assigned 327 women aged 18 to 45 with PMDD to paroxetine CR 12.5 mg, paroxetine CR 25 mg, or placebo, taken once daily for up to 3 menstrual cycles. The main measure was change in luteal-phase mood symptoms (irritability, tension, mood swings, depressed mood) on a visual rating scale.
What they found
Both doses improved mood scores significantly more than placebo (12.5 mg: difference of -8.7 mm, 95% CI -15.7 to -1.7, p = .015; 25 mg: difference of -12.1 mm, 95% CI -18.9 to -5.3, p < .001). Physical symptoms and social functioning also improved. 9.5% on 12.5 mg and 13.5% on 25 mg dropped out due to side effects, versus 6.5% on placebo.
What it means for you
Paroxetine CR, at either dose, appears to be an effective, well-tolerated option for PMDD, giving doctors flexibility in dosing. Side effects led more people to quit treatment than with placebo, which is worth weighing against the benefits.
327
Women studied
-8.7 mm
Mood improvement, 12.5 mg vs placebo
-12.1 mm
Mood improvement, 25 mg vs placebo
About the study
- Original title
- Paroxetine controlled release for premenstrual dysphoric disorder: a double-blind, placebo-controlled trial
- Authors
- Cohen LS, Soares CN, Yonkers KA et al.
- Journal
- Psychosomatic medicine
- Year
- 2004
- Study design
- Randomised trial
- Participants
- 327
- What was tested
- Paroxetine controlled-release 12.5 mg or 25 mg daily versus placebo, for up to 3 cycles.
- Read the paper
- doi.org/10.1097/01.psy.0000140005.94790.9c
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