Status:
COMPLETED
Luteal Phase Administration of Paroxetine for the Treatment of PMDD
Lead Sponsor:
Hamilton Health Sciences Corporation
Conditions:
Premenstrual Dysphoric Disorder
Eligibility:
FEMALE
18-45 years
Phase:
PHASE3
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 ad...
Eligibility Criteria
Inclusion
- PMDD according to DSM-IV criteria
Exclusion
- 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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00620581
Last Update
February 21 2008
Active Locations (1)
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1
Women's Health Concerns Clinic
Hamilton, Ontario, Canada, L8N 4A6