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Luteal Phase Administration of Paroxetine for the Treatment of PMDD (PMDD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00620581
First Posted: February 21, 2008
Last Update Posted: February 21, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
McMaster University
  Purpose
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
Premenstrual Dysphoric Disorder Drug: Paroxetine Phase 3

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

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Visual Analogue Scales

Secondary Outcome Measures:
  • PMTS-O; CGI-S; Sheehan Disability Scale

Arms Assigned Interventions
Placebo Comparator: Paroxetine 10mg;paroxetine 20mg; Placebo Drug: Paroxetine
Paroxetine 10mg and 20mg during the luteal phase of the menstrual cycle

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00620581


Locations
Canada, Ontario
Women's Health Concerns Clinic
Hamilton, Ontario, Canada, L8N 4A6
Sponsors and Collaborators
Hamilton Health Sciences Corporation
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00620581     History of Changes
Other Study ID Numbers: BRL29060/621
First Submitted: February 7, 2008
First Posted: February 21, 2008
Last Update Posted: February 21, 2008
Last Verified: November 2005

Additional relevant MeSH terms:
Premenstrual Dysphoric Disorder
Premenstrual Syndrome
Menstruation Disturbances
Pathologic Processes
Depressive Disorder
Mood Disorders
Mental Disorders
Paroxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors