Duloxetine for Major Depression in Peri-/Postmenopausal Women

Major Depressive Disorder Clinical Trial

Official title:

Duloxetine for the Treatment of Major Depression in Midlife Women: Effects on Brain Structure and Functioning, Mood, and Quality of Life

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00889369
• Other study ID #: WHCC2008-2
• Status: Recruiting
• Phase: Phase 4
• First received: April 27, 2009
• Last updated: February 7, 2012
• Start date: May 2009
• Est. completion date: June 2012

Study information

• Verified date: June 2009
• Source: McMaster University
• Contact: Stefanie M Attard
• Phone: 905-522-1155
• Email: sattard[@]stjoes.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: June 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 60 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Duloxetine
Duloxetine, flexible dose, 60-120mg/per day for 8 weeks, following a 2-week placebo lead-in phase to determine study eligibility

Locations

Country	Name	City	State
Canada	Women's Health Concerns Clinic	Hamilton	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation	Eli Lilly and Company, McMaster University, St. Joseph's Healthcare Hamilton

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effects of response to treatment with duloxetine on brain structure and activation in subjects (peri- and postmenopausal women with MDD).		10 weeks	No
Secondary	Changes in brain activation in remitters versus non-remitters after treatment with duloxetine (remission of depression defined MADRS total score <10 at study end).		10 weeks	No
Secondary	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).		10 weeks	No