Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Antidepressive Agents; Sertraline

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