Duloxetine for Major Depression in Peri-/Postmenopausal Women

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: Duloxetine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Use of duloxetine, flexible dose (60-120mg/day) for 8 weeks, following a 2-week placebo lead-in phase | Drug: Duloxetine<br>* Duloxetine, flexible dose, 60-120mg/per day for 8 weeks, following a 2-week placebo lead-in phase to determine study eligibility<br>* Other names: Cymbalta (duloxetine);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effects of response to treatment with duloxetine on brain structure and activation in subjects (peri- and postmenopausal women with MDD). |  | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression, duloxetine, menopause, imaging, FMRI, Menopausal staging, vasomotor symptoms