Duloxetine for Major Depression in Peri-/Postmenopausal Women

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2012-06-30

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.

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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.

Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Use of duloxetine, flexible dose (60-120mg/day) for 8 weeks, following a 2-week placebo lead-in phase

Group Type EXPERIMENTAL

Duloxetine

Intervention Type DRUG

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

Interventions

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Duloxetine

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

Intervention Type DRUG

Other Intervention Names

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Cymbalta (duloxetine)

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

Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes