Duloxetine for Major Depression in Peri-/Postmenopausal Women

February 7, 2012 updated by: Hamilton Health Sciences Corporation

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8P 3B6
        • Recruiting
        • Women's Health Concerns Clinic
        • Contact:
        • Principal Investigator:
          • Claudio N Soares, MD, PhD
        • Sub-Investigator:
          • Benicio N Frey, MD, PhD
        • Sub-Investigator:
          • Meir Steiner, MD, PhD
        • Sub-Investigator:
          • Geoffrey Hall, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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 Names:
  • Cymbalta (duloxetine)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
10 weeks

Secondary Outcome Measures

Outcome Measure
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).
Time Frame: 10 weeks
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).
Time Frame: 10 weeks
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamilton Health Sciences Corporation

Collaborators

St. Joseph's Healthcare Hamilton
Eli Lilly and Company
McMaster University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Anticipated)

February 1, 2012

Study Completion (Anticipated)

June 1, 2012

Study Registration Dates

First Submitted

April 27, 2009

First Submitted That Met QC Criteria

April 27, 2009

First Posted (Estimate)

April 28, 2009

Study Record Updates

Last Update Posted (Estimate)

February 8, 2012

Last Update Submitted That Met QC Criteria

February 7, 2012

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WHCC2008-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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