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

Luteal Phase Administration of Paroxetine for the Treatment of PMDD: A Randomized, Double-Blind, Placebo-Controlled Trial in Canadian Women

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.

Study Overview

• Status: Completed
• Conditions: Premenstrual Dysphoric Disorder
• Intervention / Treatment: Drug: Paroxetine

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 4A6
      • Women's Health Concerns Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Paroxetine 10mg;paroxetine 20mg; Placebo	Drug: Paroxetine; Paroxetine 10mg and 20mg during the luteal phase of the menstrual cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Visual Analogue Scales

Secondary Outcome Measures

Outcome Measure
PMTS-O; CGI-S; Sheehan Disability Scale

Collaborators and Investigators

• Sponsor: Hamilton Health Sciences Corporation

Publications and helpful links

General Publications

• 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. doi: 10.4088/jcp.v69n0616.

Study record dates

Study Registration Dates

• First Submitted: February 7, 2008
• First Submitted That Met QC Criteria: February 7, 2008
• First Posted (Estimate): February 21, 2008

Study Record Updates

• Last Update Posted (Estimate): February 21, 2008
• Last Update Submitted That Met QC Criteria: February 7, 2008
• Last Verified: November 1, 2005

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Mood Disorders; Depressive Disorder; Menstruation Disturbances; Premenstrual Syndrome; Premenstrual Dysphoric Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Paroxetine
• Other Study ID Numbers: BRL29060/621