Premenstrual Dysphoric Disorder
Conditions
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.
Interventions
DRUGParoxetine
Paroxetine 10mg and 20mg during the luteal phase of the menstrual cycle
Sponsors
Hamilton Health Sciences Corporation
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual Analogue Scales | — |
Secondary
| Measure | Time frame |
|---|---|
| PMTS-O; CGI-S; Sheehan Disability Scale | — |
Countries
Canada
Outcome results
None listed