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Duloxetine for Major Depression in Peri-/Postmenopausal Women

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ClinicalTrials.gov Identifier: NCT00889369
Recruitment Status : Unknown
Verified June 2009 by McMaster University ( Hamilton Health Sciences Corporation ).
Recruitment status was:  Recruiting
First Posted : April 28, 2009
Last Update Posted : February 8, 2012
Sponsor:
Collaborators:
Eli Lilly and Company
St. Joseph's Healthcare Hamilton
McMaster University
Information provided by (Responsible Party):
McMaster University ( Hamilton Health Sciences Corporation )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Duloxetine Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Duloxetine for the Treatment of Major Depression in Midlife Women: Effects on Brain Structure and Functioning, Mood, and Quality of Life
Study Start Date : May 2009
Estimated Primary Completion Date : February 2012
Estimated Study Completion Date : June 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: A
Use of duloxetine, flexible dose (60-120mg/day) for 8 weeks, following a 2-week placebo lead-in phase
 Drug: Duloxetine
Duloxetine, flexible dose, 60-120mg/per day for 8 weeks, following a 2-week placebo lead-in phase to determine study eligibility
Other Name: Cymbalta (duloxetine)


Outcome Measures
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Primary Outcome Measures :
  1. The effects of response to treatment with duloxetine on brain structure and activation in subjects (peri- and postmenopausal women with MDD). [ Time Frame: 10 weeks ]

Secondary Outcome Measures :
  1. Changes in brain activation in remitters versus non-remitters after treatment with duloxetine (remission of depression defined MADRS total score <10 at study end). [ Time Frame: 10 weeks ]
  2. 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). [ Time Frame: 10 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00889369


Contacts
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Contact: Stefanie M Attard 905-522-1155 ext 32048 sattard@stjoes.ca
Contact: Benicio N Frey, MD, PhD 905-522-1155 ext 35123 freybn@mcmaster.ca

Locations
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Canada, Ontario
Women's Health Concerns Clinic Recruiting
Hamilton, Ontario, Canada, L8P 3B6
Contact: Stefanie M Attard    905-522-1155 ext 32048    sattard@stjoes.ca   
Principal Investigator: Claudio N Soares, MD, PhD         
Sub-Investigator: Benicio N Frey, MD, PhD         
Sub-Investigator: Geoffrey Hall, PhD         
Sub-Investigator: Meir Steiner, MD, PhD         
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Eli Lilly and Company
St. Joseph's Healthcare Hamilton
McMaster University
Investigators
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Principal Investigator: Claudio N Soares, MD, PhD St. Joseph's Healthcare; McMaster University
More Information
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Publications of Results:

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Responsible Party: Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier: NCT00889369    
Other Study ID Numbers: WHCC2008-2
First Posted: April 28, 2009    Key Record Dates
Last Update Posted: February 8, 2012
Last Verified: June 2009
Keywords provided by McMaster University ( Hamilton Health Sciences Corporation ):
depression
duloxetine
menopause
imaging
 FMRI
Menopausal staging
vasomotor symptoms
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
 Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents