Back to resultsLuteal Phase Administration of Paroxetine for the Treatment of PMDD (PMDD)
Primary Purpose
Premenstrual Dysphoric Disorder
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Paroxetine
Sponsored by
About this trial
This is an interventional trial for Premenstrual Dysphoric Disorder
Eligibility Criteria
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.
Sites / Locations
- Women's Health Concerns Clinic
Arms of the Study
Arm 1
Arm Type
Placebo Comparator
Arm Label
Paroxetine 10mg;paroxetine 20mg; Placebo
Arm Description
Outcomes
Primary Outcome Measures
Visual Analogue Scales
Secondary Outcome Measures
PMTS-O; CGI-S; Sheehan Disability Scale
Full Information
NCT ID
NCT00620581
First Posted
February 7, 2008
Last Updated
February 7, 2008
Sponsor
Hamilton Health Sciences Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00620581
Brief Title
Luteal Phase Administration of Paroxetine for the Treatment of PMDD
Acronym
PMDD
Official Title
Luteal Phase Administration of Paroxetine for the Treatment of PMDD: A Randomized, Double-Blind, Placebo-Controlled Trial in Canadian Women
Study Type
Interventional
2. Study Status
Record Verification Date
November 2005
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Hamilton Health Sciences Corporation
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premenstrual Dysphoric Disorder
7. Study Design
Study Phase
Phase 3
8. Arms, Groups, and Interventions
Arm Title
Paroxetine 10mg;paroxetine 20mg; Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Paroxetine
Intervention Description
Paroxetine 10mg and 20mg during the luteal phase of the menstrual cycle
Primary Outcome Measure Information:
Title
Visual Analogue Scales
Secondary Outcome Measure Information:
Title
PMTS-O; CGI-S; Sheehan Disability Scale
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Women's Health Concerns Clinic
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
18517289
Citation
Steiner M, Ravindran AV, LeMelledo JM, Carter D, Huang JO, Anonychuk AM, Simpson SD. Luteal phase administration of paroxetine for the treatment of premenstrual dysphoric disorder: a randomized, double-blind, placebo-controlled trial in Canadian women. J Clin Psychiatry. 2008 Jun;69(6):991-8. doi: 10.4088/jcp.v69n0616.
Results Reference
derived
Learn more about this trial
Luteal Phase Administration of Paroxetine for the Treatment of PMDD
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