Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder

Condition(s) targeted: Premenstrual Syndrome

Intervention: Sertraline (Drug); Treatment as usual (TAU) (Other)

Phase: Phase 1/Phase 2

Status: Active, not recruiting

Sponsored by: National Institute of Mental Health (NIMH)

Official(s) and/or principal investigator(s):
Kimberly A Yonkers, MD, Principal Investigator, Affiliation: Associate Professor

This study will determine whether characteristics of women with Premenstrual Syndrome (PMS) influence response to treatment with serotonin reuptake inhibitors (SRIs) and whether SRIs can alleviate premenstrual symptoms.

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

Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Premenstrual Tension Scale (PMTS)

Secondary outcome:

Inventory of Depressive Symptomatology Clinician-rated version (IDS-C)

Patient Global Impressions scale

Quality of Life, Enjoyment, and Satisfaction Questionnaire Scale (Q-LES-Q)

Detailed description: Moderate to severe premenstrual disturbances afflict up to 20 percent of women. Studies have shown the use of 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.

Minimum age: 18 Years. Maximum age: 48 Years. Gender(s): Female.

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

Yale School of Medicine, New Haven, Connecticut 06510, United States

Starting date: September 2001
Ending date: June 2008
Last updated: December 7, 2007