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Luteal Phase Administration of Paroxetine for the Treatment of PMDD

This study has been completed.
Sponsor:
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00620581
First received: February 7, 2008
Last updated: NA
Last verified: November 2005
History: No changes posted
  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:

MedlinePlus related topics: Menstruation
U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00620581

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

No publications provided by McMaster University

Additional 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
Study First Received: February 7, 2008
Last Updated: February 7, 2008
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Premenstrual Syndrome
Menstruation Disturbances
Pathologic Processes
Paroxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013