Effect of the Menstrual Cycle on the Symptoms of Depression and Treatment Response

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Collaborator: Ontario Mental Health Foundation
• Treatments: Citalopram; Dexetimide

Criteria

Inclusion Criteria:

• Women, ages 18-65 years old

• Fulfilling DSM-IV criteria for major depressive disorder, which is not secondary to another pre-existing psychiatric condition or to a medical condition

• Hamilton Depression Rating Scale (HAM-D-17) total score of at least 16

• Able and willing to give meaningful written consent

• 28 women premenopausal (having monthly periods); 28 women perimenopausal (having irregular periods); and 28 women menopausal (without a period for at least one year).

• In good physical health.

Exclusion Criteria:

• Subjects who are taking the birth control pill currently or within the last 3 months

• Subjects who plan to become pregnant or were pregnant within the last year

• Subjects who are taking hormone replacement therapy (or received it within the last three [3] months)

• Subjects who meet DSM-IV criteria for substance abuse (consume > 4 alcoholic beverages per day)

• Subjects who have tried 2 antidepressants for this episode

• Subjects who have additional diagnosed psychiatric conditions (i.e. anxiety, substance use and psychotic disorders)

• Subjects who have had both ovaries surgically removed.