The Effect of the Menstrual Cycle on the Symptoms of Depression and Treatment Response: A Comparison of Premenopausal, Perimenopausal and Postmenopausal Women
Sponsor study identifier
interventional
44
1 country
1
Study Start
April 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2008
Actual (reported)Study Completion
October 2008
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2008
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2004
Date type not reportedThis date has not been verified as actual or estimated.
September 9, 2005
Actual (reported)September 16, 2005
Actual (reported)October 2008
Actual (reported)October 2008
Actual (reported)Hamilton Depression Rating Scale (HAM-D)
12 weeks
Clinical Global Impression (CGI)
12 weeks
Trimodal Anxiety Questionnaire (TAQ)
12 weeks
Women's Health Questionnaire
12 weeks
Prism calender
12 weeks
Biological measures (β-estradiol, estrogen, progesterone, follicle-stimulating hormone [FSH], luteinizing hormone [LH], and testosterone)
12 weeks
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University Health Network
Toronto, Ontario, M5G 2C4, Canada
Grigoriadis S, Kennedy SH, Bagby RM. A comparison of antidepressant response in younger and older women. J Clin Psychopharmacol. 2003 Aug;23(4):405-7. doi: 10.1097/01.jcp.0000085415.08426.c6.
Sophie Grigoriadis, PhD, MD, FRCPC
University Health Network, Toronto
44 participants (actual enrollment reported by the registry).
First Submitted
September 9, 2005
First Posted
September 16, 2005
Study Start
April 2004
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
October 2008
Actual (reported)Study Completion
October 2008
Actual (reported)Last Updated
March 13, 2009
Record last verified: 2007-01
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Source: ClinicalTrials.gov.
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