search
Back to results

Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder

Primary Purpose

Premenstrual Syndrome

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Sertraline
Treatment as usual (TAU)
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premenstrual Syndrome

Eligibility Criteria

18 Years - 48 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: DSM-IV criteria for Premenstrual syndrome (PMS) or Premenstrual Dysphoric Disorder (PMDD) For a diagnosis of PMS but not PMDD, patients must have 3 to 4 symptoms, complain of functional impairment as a result of their symptoms, and identify symptoms as problematic enough to warrant treatment Symptoms of PMS/PMDD in at least 9 of 12 menstrual cycles during the year prior to screening Symptom-free during the follicular phase and impairment during the luteal phase Regular menstrual cycles Adequate methods of birth control Exclusion Criteria: Major depression, bipolar disorder, or psychotic disorders Hepatitis or hepatic failure Amenorrhea, oligomenorrhea, blood dyscrasias, or illnesses for which monoamine oxidase inhibitors must be prescribed Follicular phase symptoms consistent with a diagnosis of major depression, bipolar disorder, or psychotic disorders Co-existing condition that renders the patient unsuitable for the study Risk of suicide Antidepressants or other psychotropic medication Hypersensitivity or adverse reaction to sertraline Pregnancy, breast-feeding, or plans to become pregnant during the course of the study Depot hormonal preparation or any other medication that would lead to lack of menses or markedly irregular menses

Sites / Locations

  • Yale School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Participants will receive treatment as usual

Participants will take sertraline

Outcomes

Primary Outcome Measures

Premenstrual Tension Scale (PMTS)

Secondary Outcome Measures

Inventory of Depressive Symptomatology Clinician-rated version (IDS-C)
Patient Global Impressions scale
Quality of Life, Enjoyment, and Satisfaction Questionnaire Scale (Q-LES-Q)

Full Information

First Posted
November 8, 2002
Last Updated
January 11, 2016
Sponsor
Yale University
Collaborators
National Institute of Mental Health (NIMH)
search

1. Study Identification

Unique Protocol Identification Number
NCT00048854
Brief Title
Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder
Official Title
Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will determine whether characteristics of women with Premenstrual Syndrome influence response to treatment with serotonin reuptake inhibitors and whether SRIs can alleviate premenstrual symptoms.
Detailed Description
Moderate to severe premenstrual disturbances afflict up to 20 percent of women. Studies have shown the use of serotonin reuptake inhibitors (SRIs) during the luteal phase of the menstrual cycle to be effective in improving symptoms in women with premenstrual dysphoric disorder (PMDD). Unfortunately, SRI treatment has only been evaluated in controlled clinical trials, and evidence suggests that patients in these clinical trials are not representative of women commonly seen in clinical practice. Thus, the real-world feasibility of intermittent dosing is questionable. Patients in this study receive sertraline (Zoloft) during the luteal phase of their menstrual cycle every month for 6 months. The dose may be modified based on structured interviews with the patients. Assessments include questionnaires and interviews which take place at study start, at midpoint, and at the end of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premenstrual Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Participants will receive treatment as usual
Arm Title
2
Arm Type
Experimental
Arm Description
Participants will take sertraline
Intervention Type
Drug
Intervention Name(s)
Sertraline
Other Intervention Name(s)
Zoloft
Intervention Description
Patients who meet study criteria will be given 50 mg per day of sertraline to be taken an estimated 2 weeks before menstruation.
Intervention Type
Other
Intervention Name(s)
Treatment as usual (TAU)
Other Intervention Name(s)
TAU
Intervention Description
At the TAU baseline visit, patients will be told of their diagnosis of PMS/PMDD. Those patients who decide to seek treatment outside of the study protocol or do not wish to seek treatment will be asked to participate in the TAU part of this protocol. Patients in TAU will be contacted monthly to obtain monthly information about how they have been feeling (blinded ratings) using the study measures.
Primary Outcome Measure Information:
Title
Premenstrual Tension Scale (PMTS)
Time Frame
Measured at Month 8
Secondary Outcome Measure Information:
Title
Inventory of Depressive Symptomatology Clinician-rated version (IDS-C)
Time Frame
Measured at Month 8
Title
Patient Global Impressions scale
Time Frame
Measured at Month 8
Title
Quality of Life, Enjoyment, and Satisfaction Questionnaire Scale (Q-LES-Q)
Time Frame
Measured at Month 8

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
48 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: DSM-IV criteria for Premenstrual syndrome (PMS) or Premenstrual Dysphoric Disorder (PMDD) For a diagnosis of PMS but not PMDD, patients must have 3 to 4 symptoms, complain of functional impairment as a result of their symptoms, and identify symptoms as problematic enough to warrant treatment Symptoms of PMS/PMDD in at least 9 of 12 menstrual cycles during the year prior to screening Symptom-free during the follicular phase and impairment during the luteal phase Regular menstrual cycles Adequate methods of birth control Exclusion Criteria: Major depression, bipolar disorder, or psychotic disorders Hepatitis or hepatic failure Amenorrhea, oligomenorrhea, blood dyscrasias, or illnesses for which monoamine oxidase inhibitors must be prescribed Follicular phase symptoms consistent with a diagnosis of major depression, bipolar disorder, or psychotic disorders Co-existing condition that renders the patient unsuitable for the study Risk of suicide Antidepressants or other psychotropic medication Hypersensitivity or adverse reaction to sertraline Pregnancy, breast-feeding, or plans to become pregnant during the course of the study Depot hormonal preparation or any other medication that would lead to lack of menses or markedly irregular menses
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberly A Yonkers, MD
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder

We'll reach out to this number within 24 hrs