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Duloxetine in elderly patients with GAD
NCT01118780Phase 4
Key facts
- Status
- Completed
- Start
- Oct 2010
- Primary completion
- Jul 2012
- Countries
- 9
- Sponsor
- Eli Lilly and Company
- Modality
- Small Molecules
- Drugs
- duloxetine
- Conditions
- generalized anxiety disorder (GAD)
01
Overview
Phase 4, randomised, double-blind trial in generalized anxiety disorder (GAD) comparing Duloxetine with Placebo (2 arms). Primary endpoint: Hamilton Anxiety Rating Scale Total Score at 10 weeks. Started Oct 2010; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Duloxetine
Duloxetine 30-120 mg daily
Placebo
Placebo daily
03
Who it enrols
Elderly patients with Generalized Anxiety Disorder (GAD) and MMSE >= 24.
04
Endpoints
Primary
Hamilton Anxiety Rating Scale Total Score
Secondary
Sheehan Disability Scale Global Functional Impairment Score
Hamilton Anxiety Rating Scale Subscales
Hospital Anxiety Depression Scale
Clinical Global Impressions of Improvement
Patient's Global Impressions of Improvement
Brief Pain Inventory-Modified Short Form
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form
Columbia Suicide Severity Rating Scale
05
Results
Primary endpoints met
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