Effect of the Menstrual Cycle on the Symptoms of Depression and Treatment Response
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Purpose
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 |
|---|---|
|
Major Depressive Disorder Depression |
Drug: Citalopram |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Effect of the Menstrual Cycle on the Symptoms of Depression and Treatment Response: A Comparison of Premenopausal, Perimenopausal and Postmenopausal Women |
- Hamilton Depression Rating Scale (HAM-D) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Clinical Global Impression (CGI) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Trimodal Anxiety Questionnaire (TAQ) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Women's Health Questionnaire [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Prism calender [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Biological measures (β-estradiol, estrogen, progesterone, follicle-stimulating hormone [FSH], luteinizing hormone [LH], and testosterone) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| 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) |
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Canada, Ontario | |
| University Health Network | |
| Toronto, Ontario, Canada, M5G 2C4 | |
| Principal Investigator: | Sophie Grigoriadis, PhD, MD, FRCPC | University Health Network, Toronto |
More Information
Publications:
| Responsible Party: | Sophie Grigoriadis, PhD, MD, FRCPC, University Health Network |
| ClinicalTrials.gov Identifier: | NCT00188396 History of Changes |
| Other Study ID Numbers: | 04-0225-AE |
| Study First Received: | September 9, 2005 |
| Last Updated: | March 12, 2009 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by University Health Network, Toronto:
|
Major Depressive Disorder Women's Mental Health Hormones |
Citalopram Antidepressive agents Mental Health |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Depressive Disorder, Major Behavioral Symptoms Mood Disorders Mental Disorders Antidepressive Agents Citalopram Dexetimide Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Antidepressive Agents, Second-Generation |
Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Physiological Effects of Drugs Antiparkinson Agents Anti-Dyskinesia Agents Parasympatholytics Autonomic Agents Peripheral Nervous System Agents Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents |
ClinicalTrials.gov processed this record on May 23, 2013