Duloxetine for Major Depression in Peri-/Postmenopausal Women

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by McMaster University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Eli Lilly and Company
St. Joseph's Healthcare Hamilton
McMaster University
Information provided by (Responsible Party):
McMaster University ( Hamilton Health Sciences Corporation )
ClinicalTrials.gov Identifier:
NCT00889369
First received: April 27, 2009
Last updated: February 7, 2012
Last verified: June 2009
  Purpose

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 Intervention Phase
Major Depressive Disorder
Drug: Duloxetine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: May 2009
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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

Ages Eligible for Study:   40 Years to 60 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00889369

Contacts
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
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
Principal Investigator: Claudio N Soares, MD, PhD St. Joseph's Healthcare; McMaster University
  More Information

Publications:
Responsible Party: McMaster University ( Hamilton Health Sciences Corporation )
ClinicalTrials.gov Identifier: NCT00889369     History of Changes
Other Study ID Numbers: WHCC2008-2
Study First Received: April 27, 2009
Last Updated: February 7, 2012
Health Authority: Canada: Health Canada

Keywords provided by McMaster University:
depression
duloxetine
menopause
imaging
FMRI
Menopausal staging
vasomotor symptoms

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Duloxetine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Adrenergic Uptake Inhibitors
Adrenergic Agents
Dopamine Uptake Inhibitors
Dopamine Agents

ClinicalTrials.gov processed this record on August 28, 2014