Luteal phase dosing with paroxetine controlled release (CR) in the treatment of premenstrual dysphoric disorder - 18/08/11
, Angelica Lindén Hirschberg, MD, PhD b, Richard Bergeron, MD, PhD c, Fiona Holland, MSc d, Michelle D. Gee, PhD d, Elisabeth Van Erp, MD e
Reprint requests: Meir Steiner, MD, PhD, Department Psychiatry and Behavioural Neurosciences and Obstetrics and Gynecology, McMaster University, Department of Psychiatry. Women's Health Concerns Clinic, St. Joseph's Healthcare, Hamilton, ON, Canada L8N 4A6.Abstract |
Objective |
This clinical trial evaluated luteal phase dosing with paroxetine controlled release (CR) (12.5 mg and 25 mg) in the treatment of premenstrual dysphoric disorder (PMDD).
Study design |
A multicenter, randomized, double-blind, placebo-controlled, 3-arm, fixed-dose study of luteal phase dosing with paroxetine CR in the treatment of PMDD. Three hundred seventy-three patients with PMDD were randomly assigned into the study. The primary measure of efficacy was the change from baseline in the mean luteal visual analogue scale (VAS)-Mood score. Secondary efficacy measures included disorder-specific evaluations, global assessments of disease severity, and assessments of functional impairment. Adverse events were recorded throughout the trial.
Results |
Patients treated with either dose of paroxetine CR demonstrated significantly greater improvements on the primary efficacy measure (change from baseline in mean luteal phase VAS-Mood scores) and on the majority of secondary efficacy measures compared with patients randomly assigned to placebo.
Conclusion |
For the treatment of PMDD, luteal phase dosing with 12.5 mg and 25 mg of paroxetine CR is effective and generally well tolerated.
Le texte complet de cet article est disponible en PDF.Key words : Premenstrual dysphoric disorder, Paroxetine, Luteal phase, Visual analogue scale
Plan
Vol 193 - N° 2
P. 352-360 - août 2005 Retour au numéro
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