Luteal Phase Administration of Paroxetine for the Treatment of PMDD

• Sponsor: Hamilton Health Sciences Corporation (Other)
• Overall Status: Completed
• CT.gov ID: NCT00620581
• Collaborator: (none)
• Location: 1
• Arm: 1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Premenstrual Dysphoric Disorder	Drug: Paroxetine	Phase 3

Study Design

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

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Paroxetine 10mg;paroxetine 20mg; Placebo	Drug: Paroxetine; Paroxetine 10mg and 20mg during the luteal phase of the menstrual cycle

Outcome Measures

Primary Outcome Measures

1. Visual Analogue Scales []

Secondary Outcome Measures

1. PMTS-O; CGI-S; Sheehan Disability Scale []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Women's Health Concerns Clinic	Hamilton	Ontario	Canada	L8N 4A6

Sponsors and Collaborators

• Hamilton Health Sciences Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00620581
• Other Study ID Numbers: BRL29060/621
• First Posted: Feb 21, 2008
• Last Update Posted: Feb 21, 2008
• Last Verified: Nov 1, 2005

• Additional relevant MeSH terms: Premenstrual Dysphoric Disorder; Paroxetine

Study Results

No Results Posted as of Feb 21, 2008