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Sponsors and Collaborators: |
Karolinska Institutet Novo Nordisk GlaxoSmithKline Göteborg University |
Information provided by: | Karolinska Institutet |
ClinicalTrials.gov Identifier: | NCT00516113 |
The objective of this study is to explore the onset of action when serotonin reuptake inhibitors are used to treat premenstrual dysphoric disorder
Condition | Intervention | Phase |
Premenstrual Dysphoric Disorder Premenstrual Syndrome |
Drug: paroxetine |
Phase IV |
MedlinePlus related topics: | Premenstrual Syndrome |
ChemIDplus related topics: | Paroxetine Paroxetine hydrochloride Paroxetine Mesylate Serotonin |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Placebo-Controlled Study to Investigate the Onset of Action of Paroxetine When Used for the Treatment of Premenstrual Dysphoria |
Enrollment: | 24 |
Study Start Date: | October 2000 |
Study Completion Date: | November 2002 |
Arms | Assigned Interventions |
1: Active Comparator
Paroxetine 20mg during the luteal phase of the menstrual cycle
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Drug: paroxetine
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
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2: Placebo Comparator
Placebo during the luteal phase of the menstrual cycle
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Drug: paroxetine
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
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Sweden | |||||
The Psychiatric clinic, Sahlgrenska University Hospital | |||||
Göteborg, Sweden, SE43180 |
Karolinska Institutet |
Novo Nordisk |
GlaxoSmithKline |
Göteborg University |
Principal Investigator: | Mikael SG Landen, MD, PhD | Karolinska Institutet, Stockholm, Sweden |
Study ID Numbers: | L&E-5 |
First Received: | August 13, 2007 |
Last Updated: | December 6, 2007 |
ClinicalTrials.gov Identifier: | NCT00516113 |
Health Authority: | Sweden: Medical Products Agency; Sweden: Regional Ethical Review Board |
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