Text Size

Short-Term Versus Long-Term Treatment for Severe Premenstrual Syndrome (PMS)

This study has been completed.
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00318773
First received: April 25, 2006
Last updated: February 26, 2009
Last verified: April 2006
History of Changes
  Purpose

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.


Condition Intervention Phase
Premenstrual Syndrome
 Drug: sertraline
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Short-Term Versus Long-Term Treatment for Severe PMS

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Penn Daily Symptom Report (DSR) [ Time Frame: daily ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hamilton Depression Scale [ Time Frame: monthly ] [ Designated as safety issue: No ]
  • Quality of Life Questionnaire [ Time Frame: monthly ] [ Designated as safety issue: No ]
  • Sheehan Disability Scales [ Time Frame: monthly ] [ Designated as safety issue: No ]
  • Clinical Global Rating of Severity and Improvement [ Time Frame: monthly ] [ Designated as safety issue: No ]

Enrollment: 174
Study Start Date: February 2002
Study Completion Date: February 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: sertraline
    50 - 100 mg daily for 2 weeks before each menses for 4 months or 12 months and then switched to placebo.
Detailed Description:

Severe PMS is a chronic and complex mood disorder that involves mood, behavioral and physical symptoms linked to the menstrual cycle with severity that disrupts functioning for as much as several weeks each menstrual cycle. Estimates indicate that 20-25% of menstruating women experience severe PMS. The efficacy of serotonergic antidepressants is clearly demonstrated for severe forms of PMS in short-term treatment trials. This study compares short-term treatment (4 months) and long-term treatment (12 months) with sertraline in a randomized, placebo-controlled design. The purpose is to determine how long medication should be continued following symptom relief, to what extent and how rapidly symptoms return after stopping medication, and whether there is any additional improvement with long-term treatment.

Following a screen period for 2-3 menstrual cycles that includes a placebo-treated cycle, eligible women are randomized double-blind to the short-term or long-term treatment arm. Subjects are switched (double-blind) to placebo after 4 months or 12 months of sertraline treatment. All subjects continue the study for a total of 21 months and receive either sertraline or the matching placebo in this interval. Subjects whose symptoms return are given open-label sertraline without breaking the study blind. Subjects rate symptoms daily throughout the study using the Penn Daily Symptom Report. Other assessments are conducted at monthly intervals and include the Clinical Global Impressions Rating Scale, Sheehan Disability Scale, Hamilton Depression Rating Scale, Endicott Quality of Life Questionnaire and the Cohen Perceived Stress Scale. The overall duration of the study is expected to be 5-6 years.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00318773

Locations
United States, Pennsylvania
Department of Obstetrics/Gynecology, University of Pennsylvania, School of Medicine
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: 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
  More Information

No publications provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ellen W. Freeman, PhD, Research Professor, University of Pennsylvania, Department of Obstetrics/Gynecology
ClinicalTrials.gov Identifier: NCT00318773     History of Changes
Other Study ID Numbers: RO1HD18633
Study First Received: April 25, 2006
Last Updated: February 26, 2009
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
PMS
PMDD
sertraline
 antidepressant
extended treatment
relapse

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

ClinicalTrials.gov processed this record on June 18, 2013