Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kimberly Yonkers, Yale University
ClinicalTrials.gov Identifier:
NCT00048854
First received: November 8, 2002
Last updated: August 7, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Premenstrual Syndrome
Drug: Sertraline
Other: Treatment as usual (TAU)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Premenstrual Tension Scale (PMTS) [ Time Frame: Measured at Month 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Inventory of Depressive Symptomatology Clinician-rated version (IDS-C) [ Time Frame: Measured at Month 8 ] [ Designated as safety issue: No ]
  • Patient Global Impressions scale [ Time Frame: Measured at Month 8 ] [ Designated as safety issue: No ]
  • Quality of Life, Enjoyment, and Satisfaction Questionnaire Scale (Q-LES-Q) [ Time Frame: Measured at Month 8 ] [ Designated as safety issue: No ]

Enrollment: 66
Study Start Date: September 2001
Study Completion Date: January 2008
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Participants will receive treatment as usual
Other: Treatment as usual (TAU)
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.
Other Name: TAU
Experimental: 2
Participants will take sertraline
Drug: Sertraline
Patients who meet study criteria will be given 50 mg per day of sertraline to be taken an estimated 2 weeks before menstruation.
Other Name: Zoloft

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.

  Eligibility

Ages Eligible for Study:   18 Years to 48 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00048854

Locations
United States, Connecticut
Yale School of Medicine
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Kimberly A Yonkers, MD Professor
  More Information

No publications provided

Responsible Party: Kimberly Yonkers, Professor, Yale University
ClinicalTrials.gov Identifier: NCT00048854     History of Changes
Other Study ID Numbers: R21 MH62379, R21MH062379, DSIR AT-SO
Study First Received: November 8, 2002
Last Updated: August 7, 2012
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Premenstrual Syndrome
Menstruation Disturbances
Pathologic Processes
Antidepressive Agents
Sertraline
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 July 20, 2014