Luteal Phase Administration of Paroxetine for the Treatment of PMDD
Sponsored by Hamilton Health Sciences Corporation
About this trial
Last updated 17 years ago
Study ID
BRL29060/621
Status
Completed
Type
Interventional
Phase
Phase 3
Placebo
No
Accepting
18 to 45 Years
Female
Not accepting
Healthy Volunteers
What is this trial about?
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.
What are the participation requirements?
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.