Clinical trial NCT00889369: Duloxetine for Major Depression in Peri-/Postmenopausal Women
Official title: Duloxetine for the Treatment of Major Depression in Midlife Women: Effects on Brain Structure and Functioning, Mood, and Quality of Life
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Major Depressive Disorder
Keywords: depression
duloxetine
menopause
imaging
FMRI
Menopausal staging
vasomotor symptoms
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
name: St. Joseph's Healthcare Hamilton
name: McMaster University
First posted: 2009-04-28
Enrollment: 70
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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 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.

Eligibility 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

Primary outcomes:
measure: The effects of response to treatment with duloxetine on brain structure and activation in subjects (peri- and postmenopausal women with MDD).
timeFrame: 10 weeks
Secondary outcomes:
measure: Changes in brain activation in remitters versus non-remitters after treatment with duloxetine (remission of depression defined MADRS total score <10 at study end).
timeFrame: 10 weeks
measure: Correlations between changes in brain activation and changes from baseline to study end and menopausal symptoms, depressive symptoms, cognition, quality of life, and clinical global impression (improvement and severity).
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Women's Health Concerns Clinic
state: Ontario
Study officials:
affiliation: St. Joseph's Healthcare; McMaster University
name: Claudio N Soares, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Frey BN, Hall GB, Attard S, Yucel K, Skelin I, Steiner M, Soares CN. Shift in the brain network of emotional regulation in midlife women: is the menopausal transition the turning point? Menopause. 2010 Jul;17(4):840-5. doi: 10.1097/gme.0b013e3181df840f.