NCT00318773

Brief Summary

Serotonergic antidepressants are clearly effective for premenstrual syndrome (PMS). This study compares short-term treatment (4 months) and long-term treatment (12 months) with sertraline to determine how long medication should be continued after achieving a good response, how soon symptoms return after stopping medication, and whether symptoms are further improved with long-term treatment. Multiple hypotheses include the following: The percent of relapsed subjects is greater with short-term treatment; relapse is swifter with short-term treatment; relapsed subjects improve swiftly when returned to medication; patient satisfactions and quality of life are more improved with long-term treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
174

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2002

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2002

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

April 25, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 27, 2006

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

February 27, 2009

Status Verified

April 1, 2006

Enrollment Period

5.8 years

First QC Date

April 25, 2006

Last Update Submit

February 26, 2009

Conditions

Premenstrual Syndrome

Keywords

PMSPMDDsertralineantidepressantextended treatmentrelapse

Outcome Measures

Primary Outcomes (1)

  • Penn Daily Symptom Report (DSR)

    daily

Secondary Outcomes (4)

  • Hamilton Depression Scale

    monthly

  • Quality of Life Questionnaire

    monthly

  • Sheehan Disability Scales

    monthly

  • Clinical Global Rating of Severity and Improvement

    monthly

Interventions

sertralineDRUG

50 - 100 mg daily for 2 weeks before each menses for 4 months or 12 months and then switched to placebo.

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women with PMS for at least 1 year.
  • Ages 18-45 years
  • Regular menstrual cycles in normal range (22-36 days) for at least 6 months
  • In general good health as determined by physical examination and blood tests.
  • Evidence of ovulation using a urine test.
  • Meeting stated criteria for PMS.
  • Signed informed consent.

You may not qualify if:

  • Any prescription, over-the-counter, herbal or non-medical therapies for PMS.
  • Use of psychotropic medications that cannot be stopped for the duration of the study.
  • Other current psychiatric diagnoses as determined by SCID interview.
  • Alcohol or substance abuse/dependence or suicide attempt within the past 12 months; lifetime history of psychosis, bipolar disorder and clearly identifiable severe personality disorder.
  • Hysterectomy, symptomatic endometriosis, irregular menstrual cycles,any severe or unstable medical illness.
  • Lack of medically-approved contraception, currently pregnant, intention to become pregnant or breast feeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics/Gynecology, University of Pennsylvania, School of Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Freeman EW, Rickels K, Sammel MD, Lin H, Sondheimer SJ. Time to relapse after short- or long-term treatment of severe premenstrual syndrome with sertraline. Arch Gen Psychiatry. 2009 May;66(5):537-44. doi: 10.1001/archgenpsychiatry.2008.547.

    PMID: 19414713DERIVED

MeSH Terms

Conditions

Premenstrual SyndromeRecurrence

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Intervention Hierarchy (Ancestors)

1-NaphthylamineAminesOrganic ChemicalsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • Ellen W Freeman, PhD

    University of Pennsylvania, School of Medicine, Department of Ob/Gyn

    PRINCIPAL INVESTIGATOR

  • Steven J Sondheimer, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

  • Karl Rickels, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

April 25, 2006

First Posted

April 27, 2006

Study Start

February 1, 2002

Primary Completion

December 1, 2007

Study Completion

February 1, 2008

Last Updated

February 27, 2009

Record last verified: 2006-04

Locations

US(1)