Luteal Phase Administration of Paroxetine for the Treatment of PMDD - Full Text View

Sponsored by:	Hamilton Health Sciences
Information provided by:	McMaster University
ClinicalTrials.gov Identifier:	NCT00620581

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 III

MedlinePlus related topics: Menstruation

Drug Information available for: Paroxetine Paroxetine hydrochloride Paroxetine Mesylate

U.S. FDA Resources

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

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
Paroxetine 10mg;paroxetine 20mg; Placebo: Placebo Comparator	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

More Information

Publications indexed to this study:

Steiner M, Ravindran AV, LeMelledo JM, Carter D, Huang JO, Anonychuk AM, Simpson SD. Luteal phase administration of paroxetine for the treatment of premenstrual dysphoric disorder: a randomized, double-blind, placebo-controlled trial in Canadian women. J Clin Psychiatry. 2008 Jun;69(6):991-8.

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

Study placed in the following topic categories:

Depression
Menstruation Disturbances
Mental Disorders
Mood Disorders

Depressive Disorder
Paroxetine
Serotonin
Premenstrual Syndrome

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on January 16, 2009