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

Primary Purpose

Premenstrual Syndrome

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
sertraline
Sponsored by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premenstrual Syndrome focused on measuring PMS, PMDD, sertraline, antidepressant, extended treatment, relapse

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

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

Outcomes

Primary Outcome Measures

Penn Daily Symptom Report (DSR)

Secondary Outcome Measures

Hamilton Depression Scale
Quality of Life Questionnaire
Sheehan Disability Scales
Clinical Global Rating of Severity and Improvement

Full Information

First Posted
April 25, 2006
Last Updated
February 26, 2009
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT00318773
Brief Title
Short-Term Versus Long-Term Treatment for Severe Premenstrual Syndrome (PMS)
Official Title
Short-Term Versus Long-Term Treatment for Severe PMS
Study Type
Interventional

2. Study Status

Record Verification Date
April 2006
Overall Recruitment Status
Completed
Study Start Date
February 2002 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premenstrual Syndrome
Keywords
PMS, PMDD, sertraline, antidepressant, extended treatment, relapse

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
174 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
sertraline
Intervention Description
50 - 100 mg daily for 2 weeks before each menses for 4 months or 12 months and then switched to placebo.
Primary Outcome Measure Information:
Title
Penn Daily Symptom Report (DSR)
Time Frame
daily
Secondary Outcome Measure Information:
Title
Hamilton Depression Scale
Time Frame
monthly
Title
Quality of Life Questionnaire
Time Frame
monthly
Title
Sheehan Disability Scales
Time Frame
monthly
Title
Clinical Global Rating of Severity and Improvement
Time Frame
monthly

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen W Freeman, PhD
Organizational Affiliation
University of Pennsylvania, School of Medicine, Department of Ob/Gyn
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Steven J Sondheimer, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karl Rickels, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Obstetrics/Gynecology, University of Pennsylvania, School of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19414713
Citation
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.
Results Reference
derived

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

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