Official Title: “Luteal Phase Administration of Paroxetine for the Treatment of PMDD: A Randomized, Double-Blind, Placebo-Controlled Trial in Canadian Women”

The efficacy of SSRI use to relieve the symptoms associated with premenstrual dysphoric disorder has been established. We proposed to test the hypothesis that intermittent treatment with paroxetine administered during the luteal phase of the menstrual cycle only is more effective than placebo in improving symptoms of PMDD. This was a double-blind, placebo-controlled, three-arm parallel group study of patients with PMDD. Menstruating women 18 years of age or older who met criteria for inclusion in the study were randomized to one of three arms: paroxetine 10mg/day during the luteal phase of the menstrual cycle; paroxetine 20mg/day during the luteal phase of the menstrual cycle; placebo daily during the luteal phase of the menstrual cycle. The objective was to evaluate the efficacy and safety of intermittent treatment of paroxetine in women with PMDD.

Study Type: Interventional

Study Design: N/A

Intervention(s) in this Clinical Trial

• Drug: Paroxetine
  • Paroxetine 10mg and 20mg during the luteal phase of the menstrual cycle

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: Paroxetine 10mg;paroxetine 20mg; Placebo

Primary Measures

• Visual Analogue Scales

Secondary Measures

• PMTS-O; CGI-S; Sheehan Disability Scale

Inclusion Criteria:

• PMDD according to DSM-IV criteria

Exclusion Criteria:

• Women were excluded if they were taking oral contraception, breast-feeding, pregnant, or planning to become pregnant during the study period.
• Women were also excluded if they met DSM-IV criteria for any Axis I disorder, were deemed a suicidal risk, had a history of SSRI use for premenstrual symptoms, were taking ongoing medication that could affect PMDD symptoms, had a clinically significant abnormality on screening blood tests, or had a baseline Montgomery-Asberg
• Depression Rating Scale score of equal to or greater than 10 during the follicular phase of the menstrual cycle.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Hamilton Health Sciences

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00620581

Study ID Number: BRL29060/621

ClinicalTrials.gov Identifier: NCT00620581

Health Authority: Canada: Health Canada