Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder

Yale University

Status and phase

Completed

Phase 2

Phase 1

Conditions

Premenstrual Syndrome

Treatments

Other: Treatment as usual (TAU)

Drug: Sertraline

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00048854

R21MH062379 (U.S. NIH Grant/Contract)

DSIR AT-SO

0108012595

Details and patient eligibility

About

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.

Full 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.

Enrollment

66 patients

Sex

Female

Ages

18 to 48 years old

Volunteers

No 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