Recruiting

Duloxetine

Sponsor:

Hamilton Health Sciences Corporation

Code:

NCT00889369

Conditions

Major Depressive Disorder

Eligibility Criteria

Sex: Female

Age: 40 - 60

Healthy Volunteers: Accepted

Interventions

Duloxetine

Study Details

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.

Conditions

Major Depressive Disorder

Study ID

NCT00889369

Start date

May, 2009

Status verified date

Jun, 2009

Completion date

Jun, 2012

Anticipated

Primary completion date

Feb, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 40 - 60

Healthy Volunteers: Accepted

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 Design

Enrollment

70 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: A

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

Interventions

Duloxetine

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Stefanie M Attard

905-522-1155sattard@stjoes.ca

Benicio N Frey, MD, PhD

905-522-1155freybn@mcmaster.ca

Locations

Women's Health Concerns Clinic

Recruiting

Hamilton, Ontario, Canada, L8P 3B6

Contacts

Stefanie M Attard

905-522-1155sattard@stjoes.ca

Principal Investigator:

Claudio N Soares, MD, PhD

More Information

Sponsor

Hamilton Health Sciences Corporation

Last update posted

Feb 8, 2012

Last verified

Jun, 2009

Keywords

  • depression
  • duloxetine
  • menopause
  • imaging
  • FMRI
  • Menopausal staging
  • vasomotor symptoms

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hamilton Health Sciences Corporation on 2012-02-08.