Major Depressive Disorder | Duloxetine for Major Depression in Peri-/Postmenopausal Women
Major Depressive Disorder research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Major Depressive Disorder
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:DuloxetineDuloxetine, flexible dose, 60-120mg/per day for 8 weeks, following a 2-week placebo lead-in phase to determine study eligibility
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
AUse of duloxetine, flexible dose (60-120mg/day) for 8 weeks, following a 2-week placebo lead-in phase
Start Date: May 2009
Completed Date: June 2012
Phase: Phase 4
Primary Outcome: The effects of response to treatment with duloxetine on brain structure and activation in subjects (peri- and postmenopausal women with MDD).
Secondary Outcome: Changes in brain activation in remitters versus non-remitters after treatment with duloxetine (remission of depression defined MADRS total score <10 at study end).
Study sponsors, principal investigator, and references
Principal Investigator: Claudio N Soares, MD, PhD
Lead Sponsor: Hamilton Health Sciences Corporation
Collaborator: Eli Lilly and Company
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.