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Sponsored by: |
Hamilton Health Sciences |
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Information provided by: | McMaster University |
ClinicalTrials.gov Identifier: | NCT00620581 |
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.
Condition | Intervention | Phase |
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Premenstrual Dysphoric Disorder |
Drug: Paroxetine |
Phase III |
Study Type: | Interventional |
Official Title: | Luteal Phase Administration of Paroxetine for the Treatment of PMDD: A Randomized, Double-Blind, Placebo-Controlled Trial in Canadian Women |
Arms | Assigned Interventions |
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Paroxetine 10mg;paroxetine 20mg; Placebo: Placebo Comparator |
Drug: Paroxetine
Paroxetine 10mg and 20mg during the luteal phase of the menstrual cycle
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Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | BRL29060/621 |
Study First Received: | February 7, 2008 |
Last Updated: | February 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00620581 |
Health Authority: | Canada: Health Canada |
Depression Menstruation Disturbances Mental Disorders Mood Disorders |
Depressive Disorder Paroxetine Serotonin Premenstrual Syndrome |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Serotonin Uptake Inhibitors Pharmacologic Actions |
Pathologic Processes Serotonin Agents Therapeutic Uses Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |