Luteal Phase Administration of Paroxetine for the Treatment of PMDD

NCT00620581 | Completed Phase 3

• 1 other identifier: BRL29060/621
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Premenstrual Dysphoric Disorder

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scales

Secondary Outcomes (1)

• PMTS-O; CGI-S; Sheehan Disability Scale

Study Arms (1)

Paroxetine 10mg;paroxetine 20mg; Placebo

PLACEBO COMPARATOR

Drug: Paroxetine

Interventions

Paroxetine DRUG

Paroxetine 10mg and 20mg during the luteal phase of the menstrual cycle

Paroxetine 10mg;paroxetine 20mg; Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• PMDD according to DSM-IV criteria

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

Study Sites (1)

Women's Health Concerns Clinic

Hamilton, Ontario, L8N 4A6, Canada

Location

Related Publications (1)

• 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.

  PMID: 18517289 DERIVED

MeSH Terms

Conditions

Premenstrual Dysphoric Disorder

Interventions

Paroxetine

Condition Hierarchy (Ancestors)

Premenstrual Syndrome; Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 7, 2008
• First Posted: February 21, 2008
• Last Updated: February 21, 2008

Record last verified: 2005-11

Locations

CA (1)