Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder

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.

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