Luteal Phase Administration of Paroxetine for the Treatment of PMDD

Premenstrual Dysphoric Disorder Clinical Trial

— PMDD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00620581
• Other study ID #: BRL29060/621
• Status: Completed
• Phase: Phase 3
• First received: February 7, 2008
• Last updated: February 7, 2008

Study information

• Verified date: November 2005
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

N/A

Related Conditions & MeSH terms

• Premenstrual Dysphoric Disorder

Intervention

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

Locations

Country	Name	City	State
Canada	Women's Health Concerns Clinic	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scales
Secondary	PMTS-O; CGI-S; Sheehan Disability Scale