Luteal phase dosing with paroxetine controlled release (CR) in the treatment of premenstrual dysphoric disorder.
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).


METHODS
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.


CONCLUSIONS
For the treatment of PMDD, luteal phase dosing with 12.5 mg and 25 mg of paroxetine CR is effective and generally well tolerated.
Steiner
Meir
M
Department of Psychiatry and Behavioural Neurosciences and Obstetrics and Gynecology, McMaster University, St Joseph's Hospital, Hamilton, Ontario, Canada. mst@mcmaster.ca
Hirschberg
Angelica Lindén
AL
Bergeron
Richard
R
Holland
Fiona
F
Gee
Michelle D
MD
Van Erp
Elisabeth
E
D000293:Adolescent; D000328:Adult; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008183:Luteal Phase; D008875:Middle Aged; D010147:Pain Measurement; D017374:Paroxetine / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D011293:Premenstrual Syndrome / Q000188:drug therapy*; D017367:Selective Serotonin Reuptake Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use
D003692:Delayed-Action Preparations; D017374:Paroxetine; D017367:Selective Serotonin Reuptake Inhibitors