Clinical Trial: Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder

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 Summary:

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.


Sponsor: Yale University

Current Primary Outcome: Premenstrual Tension Scale (PMTS) [ Time Frame: Measured at Month 8 ]

Original Primary Outcome:

Current Secondary Outcome:

  • Inventory of Depressive Symptomatology Clinician-rated version (IDS-C) [ Time Frame: Measured at Month 8 ]
  • Patient Global Impressions scale [ Time Frame: Measured at Month 8 ]
  • Quality of Life, Enjoyment, and Satisfaction Questionnaire Scale (Q-LES-Q) [ Time Frame: Measured at Month 8 ]


Original Secondary Outcome:

Information By: Yale University

Dates:
Date Received: November 8, 2002
Date Started: September 2001
Date Completion:
Last Updated: January 11, 2016
Last Verified: January 2016