Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder

Completed · Phase 1/Phase 2

Conditions studied: Premenstrual Syndrome

In brief

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.

Key facts

Study ID

NCT00048854

Run by

Yale University

People needed

66

Starts

2001-09-01

Expected to finish

2008-01-01

Last updated by the study team

2016-01-12

Who can join

Age: 18 and older, up to 48. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Yale School of Medicine — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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