Status:
UNKNOWN
Duloxetine for Major Depression in Peri-/Postmenopausal Women
Lead Sponsor:
Hamilton Health Sciences Corporation
Collaborating Sponsors:
Eli Lilly and Company
St. Joseph's Healthcare Hamilton
Conditions:
Major Depressive Disorder
Eligibility:
FEMALE
40-60 years
Phase:
PHASE4
Brief Summary
The main objective of this study is to characterize a range of brain activation symptoms associated with major depression in peri- and post-menopausal women. Also, assessing brain activation before an...
Detailed Description
Women approaching menopause and during the post-menopausal years appear to be at greater risk for developing major depressive episodes. Moreover, this period in life has been associated with significa...
Eligibility Criteria
Inclusion
- peri-/postmenopausal women, aged 40-60 year
- moderate to severe major depressive episode
Exclusion
- DSM-IV Axis I diagnosis other than MDD
- contraindications to magnetic resonance imaging
- treatment-resistent
- previous failed treatment with duloxetine
- history of substance abuse or dependence in past year
- serious suicidal risk
- use of other psychotropic medications
- electroconvulsive therapy or transmagnetic stimulation in past year
- history of allergic reactions to duloxetine
- significant laboratory abnormalities at baseline
- severe hepatic impairment
- end stage renal disease and undergoing dialysis
- uncontrolled narrow-angle glaucoma
- uncontrolled or untreated hyper-/hypothyroidism, or abnormal thyroid stimulating hormone concentration
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2012
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00889369
Start Date
May 1 2009
End Date
June 1 2012
Last Update
February 8 2012
Active Locations (1)
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1
Women's Health Concerns Clinic
Hamilton, Ontario, Canada, L8P 3B6