Duloxetine for Major Depression in Peri-/Postmenopausal Women

Hamilton Health Sciences (HHS)

Status and phase

Unknown

Phase 4

Conditions

Major Depressive Disorder

Treatments

Drug: Duloxetine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00889369

WHCC2008-2

Details and patient eligibility

About

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.

Full 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 significant functional impairment due to the presence/severity of vasomotor symptoms (hot flashes, night sweats), cognitive complaints, and poorer quality of life. In light of recent controversies involving the use of hormone therapies, most physicians and patients are seeking nonhormonal strategies to alleviate menopause-related physical and emotional complaints. Duloxetine has been shown to improve major depressive disorder (MDD) and menopause-related symptoms. To date, the effects of this agent on brain structure and functioning in midlife women with MDD have not been explored. The present study aims to investigate the effects of duloxetine on brain structure and functioning when used for the treatment of a major depressive episode in menopausal women using anatomical magnetic resonance imaging (MRI) and functional MRI (fMRI). In addition, the investigators will examine whether the impact of treatment with duloxetine on vasomotor symptoms, cognition, and quality of life modulate the putative changes in brain structure and functioning.

Enrollment

70 estimated patients

Sex

Female

Ages

40 to 60 years old

Volunteers

Accepts Healthy Volunteers

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