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Sponsors and Collaborators: |
University Health Network, Toronto Ontario Mental Health Foundation |
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Information provided by: | University Health Network, Toronto |
ClinicalTrials.gov Identifier: | NCT00188396 |
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.
Condition | Intervention |
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Major Depressive Disorder Depression |
Drug: Citalopram |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | The Effect of the Menstrual Cycle on the Symptoms of Depression and Treatment Response: A Comparison of Premenopausal, Perimenopausal and Postmenopausal Women |
Enrollment: | 44 |
Study Start Date: | April 2004 |
Study Completion Date: | October 2008 |
Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Ontario | |
University Health Network | |
Toronto, Ontario, Canada, M5G 2C4 |
Principal Investigator: | Sophie Grigoriadis, PhD, MD, FRCPC | University Health Network, Toronto |
Responsible Party: | University Health Network ( Sophie Grigoriadis, PhD, MD, FRCPC ) |
Study ID Numbers: | 04-0225-AE |
Study First Received: | September 9, 2005 |
Last Updated: | March 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00188396 History of Changes |
Health Authority: | Canada: Ethics Review Committee |
Major Depressive Disorder Women's Mental Health Hormones |
Citalopram Antidepressive agents Mental Health |
Neurotransmitter Agents Depression Cholinergic Antagonists Psychotropic Drugs Depressive Disorder, Major Cholinergic Agents Depressive Disorder Serotonin Uptake Inhibitors Citalopram Hormones |
Serotonin Behavioral Symptoms Muscarinic Antagonists Mental Disorders Mood Disorders Peripheral Nervous System Agents Dexetimide Antidepressive Agents, Second-Generation Antidepressive Agents |
Parasympatholytics Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Antiparkinson Agents Depressive Disorder, Major Cholinergic Agents Mental Disorders Therapeutic Uses Antidepressive Agents, Second-Generation |
Dexetimide Antidepressive Agents Depression Depressive Disorder Citalopram Serotonin Uptake Inhibitors Pharmacologic Actions Behavioral Symptoms Muscarinic Antagonists Serotonin Agents Autonomic Agents Mood Disorders Peripheral Nervous System Agents Central Nervous System Agents |