A Placebo-Controlled Study to Investigate the Onset of Action of Paroxetine in Premenstrual Dysphoria
Information source: Karolinska Institutet
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Condition(s) targeted: Premenstrual Dysphoric Disorder; Premenstrual Syndrome
Intervention: paroxetine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Karolinska Institutet Official(s) and/or principal investigator(s): Mikael SG Landen, MD, PhD, Principal Investigator, Affiliation: Karolinska Institutet, Stockholm, Sweden
Summary
The objective of this study is to explore the onset of action when serotonin reuptake
inhibitors are used to treat premenstrual dysphoric disorder
Clinical Details
Official title: A Placebo-Controlled Study to Investigate the Onset of Action of Paroxetine When Used for the Treatment of Premenstrual Dysphoria
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: The number of patients reaching sustained remission (irritability) for each time point
Secondary outcome: Self rated irritability at each time point
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
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.
Exclusion Criteria:
- Any concomitant psychiatric disorder for which SRIs are known to be effective.
- Any other concomitant psychiatric disorder that, in the investigator's opinion, would
render the patient unsuitable for the study.
- Any somatic disorder that, in the investigator's opinion, would render the patient
unsuitable for the study.
- Any ongoing medication which, in the opinion of the investigator, would render the
patient unsuitable for the study. Examples of medications that preclude participation
in the study are: 1) any psychotropic drug, with the exception of the occasional use
of hypnotics, 2) any hormonal preparation, with the exception of thyroid hormone, 3)
anti-coagulants, and 4) 5HT1D agonists. Occasional use of analgesic compounds does
not preclude participation.
- Patient characteristics which, in the opinion of the investigator, are likely to
reduce compliance with the protocol.
Locations and Contacts
The Psychiatric clinic, Sahlgrenska University Hospital, Göteborg SE43180, Sweden
Additional Information
Starting date: October 2000
Last updated: December 6, 2007
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