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Sertraline for Depression in Alzheimer's Disease
NCT00086138Phase 3
Key facts
- Status
- Completed
- Start
- Jul 2004
- Primary completion
- Jul 2008
- Countries
- 1
- Sponsor
- Johns Hopkins University
- Modality
- Small Molecules
- Drugs
- sertraline
- Conditions
- major depressive disorder (MDD)
01
Overview
Phase 3, randomised, double-blind trial in major depressive disorder (MDD) comparing Sertraline with Placebo (2 arms). Primary endpoint: Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change at 12 weeks. Started Jul 2004; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Sertraline
Sertraline 25-125 mg daily
Placebo
Placebo matched to sertraline
03
Who it enrols
Patients with dementia due to Alzheimer's disease and co-morbid depression (meeting criteria for depression of Alzheimer's disease). Must have a caregiver.
04
Endpoints
Primary
Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change
Secondary
Remission According to Cornell Scale for Depression in Dementia
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