Effect of the Menstrual Cycle on the Symptoms of Depression and Treatment Response
Status:
Completed
Trial end date:
2008-10-01
Target enrollment:
Participant gender:
Summary
Objectives: This prospective investigation will compare premenopausal, perimenopausal and
postmenopausal women's response to antidepressant medication. The effects of the menstrual
cycle on the symptoms of depression and antidepressant response will also be examined.
Hypotheses: Premenopausal women will show a significantly better response to a selective
serotonin reuptake inhibitor (SSRI) than peri- or postmenopausal women. Premenopausal women
during lower estrogen phases of the menstrual cycle will complain of increased depressive
symptoms despite treatment. Perimenopausal and postmenopausal women with irregular periods
and generally low estrogen levels will show less symptom variability over time.
Method
Subjects: Eighty-four women (28 premenopausal, 28 perimenopausal, 28 postmenopausal) meeting
Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for
major depressive disorder will be enrolled in the study.
Procedure: All the subjects will be followed prospectively for 12 weeks and through 2
menstrual cycles while receiving treatment with a standard SSRI antidepressant agent. All
eligible women will have a structured clinical interview and will complete questionnaires
assessing their depressive symptoms. Blood samples will be collected to evaluate for
reproductive hormone levels during the late follicular, midluteal and late luteal phases of
the menstrual cycle for two consecutive cycles. Serum SSRI levels will also be collected at
these times. As the women in the perimenopausal and postmenopausal groups either have
irregular menstrual cycles or no longer cycle, they will have blood samples drawn at baseline
and on 6 other occasions.
Research Implications: As the majority of psychiatric medication is prescribed to women,
understanding the interplay between the menstrual cycle and antidepressant medication will
ultimately translate into more diverse and improved patient care. The proposed study is one
within a developing research program, which will in part be further guided by this study.