Duloxetine for Major Depression in Peri-/Postmenopausal Women

• Status: Unknown status
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: Female

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 and after the treatment might help to uncover some mechanisms associated with the pathophysiology of depression and menopause.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hamilton Health Sciences Corporation
• Collaborators: Eli Lilly and Company; McMaster University; St. Joseph's Healthcare Hamilton
• Treatments: Duloxetine Hydrochloride

Criteria

Inclusion Criteria:

• peri-/postmenopausal women, aged 40-60 year

• moderate to severe major depressive episode

Exclusion Criteria:

• 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