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Duloxetine for MDD in Midlife Women
NCT00889369Phase 4
Key facts
- Status
- Unknown
- Start
- May 2009
- Primary completion
- Feb 2012
- Countries
- 1
- Sponsor
- Hamilton Health Sciences
- Modality
- Small Molecules
- Drugs
- duloxetine
- Conditions
- major depressive disorder (MDD)
01
Overview
Phase 4, open-label, single-arm trial of duloxetine in major depressive disorder (MDD), sponsored by Hamilton Health Sciences. Primary endpoint: Effects of response to treatment with duloxetine on brain structure and activation at 10 weeks. Status: unknown.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Duloxetine
Experimental arm receiving Duloxetine
03
Who it enrols
Peri-/postmenopausal women aged 40-60 with moderate to severe MDD. Excludes treatment-resistant depression, previous failure with duloxetine, substance abuse, serious suicide risk, and other significant medical or psychiatric conditions.
04
Endpoints
Primary
Effects of response to treatment with duloxetine on brain structure and activation
Secondary
Changes in brain activation in remitters versus non-remitters after treatment with duloxetine
Correlations between changes in brain activation and changes in menopausal symptoms, depressive symptoms, cognition, quality of life, and clinical global impression
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