Status:
COMPLETED
Effect of the Menstrual Cycle on the Symptoms of Depression and Treatment Response
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Ontario Mental Health Foundation
Conditions:
Major Depressive Disorder
Depression
Eligibility:
FEMALE
18-65 years
Phase:
NA
Brief 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 sympto...
Detailed Description
Rationale: The lifetime prevalence of depression is twice as high in women as in men; this is a robust and frequently replicated finding in cross national epidemiology studies. Women are also more pro...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00188396
Start Date
April 1 2004
End Date
October 1 2008
Last Update
March 13 2009
Active Locations (1)
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1
University Health Network
Toronto, Ontario, Canada, M5G 2C4