Premenstrual Dysphoric Disorder, Premenstrual Syndrome
Conditions
Keywords
paroxetine, onset of action, serotonin reuptake inhibitors
Brief summary
The objective of this study is to explore the onset of action when serotonin reuptake inhibitors are used to treat premenstrual dysphoric disorder
Detailed description
Whereas serotonin reuptake inhibitors (SRIs) usually require weeks of treatment to effectively counteract depressed mood or anxiety, several studies suggest that they may reduce the symptoms irritability and anger more rapidly. In line with this, SRIs have been shown to reduce certain symptoms, including irritability, in women with premenstrual dysphoric disorder (PMDD) when the drug only is administered from ovulation to menstruation only, which indicates an onset of action of 10 days or less. How fast this effect appears in terms of hours or days is, however, not known. The objective of this study was to explore this issue.
Interventions
DRUGparoxetine
Capsules containing either placebo or paroxetine 20 mg. The treatment start after ovulation and when the subject has experienced premenstrual irritability for 2 days. The dosage is one capsule daily at 8 AM
Sponsors
Novo Nordisk A/S
GlaxoSmithKline
Göteborg University
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The patient should have participated in an ongoing placebo-controlled trial regarding the effect of paroxetine in PMD; to be included in that trial, she must have fulfilled the diagnostic criteria A-C of PMDD in DSM-IV and certain other inclusion and
Exclusion criteria
which are listed in appendix 1. * The patient should a) have been given paroxetine during the previous trial, b) have reported that she has been much improved or very much improved by this treatment, c) have displayed a marked reduction in VAS-rated irritability during treatment, and d) have reported that she has found the side-effects tolerable. * The patient should display at least a 50% increase in VAS-rated irritability during the luteal phase (mean of last five days prior to menses) as compared the follicular phase (days 6-10) during one cycle of pretreatment symptom rating (without medication). * The patient should have given written informed consent to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of patients reaching sustained remission (irritability) for each time point | — |
Secondary
| Measure | Time frame |
|---|---|
| Self rated irritability at each time point | — |
Countries
Sweden
Outcome results
None listed