NCT00889369

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for phase_4 major-depressive-disorder

Timeline
Completed

Started May 2009

Typical duration for phase_4 major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 28, 2009

Completed
3 days until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

February 8, 2012

Status Verified

June 1, 2009

Enrollment Period

2.8 years

First QC Date

April 27, 2009

Last Update Submit

February 7, 2012

Conditions

Major Depressive Disorder

Keywords

depressionduloxetinemenopauseimagingFMRIMenopausal stagingvasomotor symptoms

Outcome Measures

Primary Outcomes (1)

  • The effects of response to treatment with duloxetine on brain structure and activation in subjects (peri- and postmenopausal women with MDD).

    10 weeks

Secondary Outcomes (2)

  • 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

Study Arms (1)

A

EXPERIMENTAL

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

Drug: Duloxetine

Interventions

DuloxetineDRUG

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

Also known as: Cymbalta (duloxetine)
A

Eligibility Criteria

Age40 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • peri-/postmenopausal women, aged 40-60 year
  • moderate to severe major depressive episode

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women's Health Concerns Clinic

Hamilton, Ontario, L8P 3B6, Canada

RECRUITING

Related Publications (1)

  • Frey BN, Hall GB, Attard S, Yucel K, Skelin I, Steiner M, Soares CN. Shift in the brain network of emotional regulation in midlife women: is the menopausal transition the turning point? Menopause. 2010 Jul;17(4):840-5. doi: 10.1097/gme.0b013e3181df840f.

    PMID: 20616670RESULT

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Claudio N Soares, MD, PhD

    St. Joseph's Healthcare; McMaster University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefanie M Attard

CONTACT

905-522-1155sattard@stjoes.ca

Benicio N Frey, MD, PhD

CONTACT

905-522-1155freybn@mcmaster.ca

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2009

First Posted

April 28, 2009

Study Start

May 1, 2009

Primary Completion

February 1, 2012

Study Completion

June 1, 2012

Last Updated

February 8, 2012

Record last verified: 2009-06

Locations

CA(1)