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Escitalopram and CBT for Depression in African Americans with Type 2 Diabetes
NCT00209170Phase 4
Key facts
- Status
- Completed
- Start
- May 2004
- Primary completion
- May 2008
- Countries
- 1
- Sponsor
- Emory University
- Modality
- Small Molecules
- Drugs
- escitalopram
- Conditions
- major depressive disorder (MDD)
01
Overview
Phase 4, randomised, double-blind trial in major depressive disorder (MDD) comparing Escitalopram + CBT with Placebo + CBT (2 arms). Primary endpoint: Change in Hamilton Depression Rating Scale at 24 weeks. Started May 2004; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Escitalopram + CBT
Escitalopram 10 mg daily + Beating the Blues CBT
Placebo + CBT
Placebo + Beating the Blues CBT
03
Who it enrols
African American patients with Type 2 diabetes and major depression, excluding those with severe depression (HAM-D >= 34), uncontrolled diabetes, or other significant psychiatric or medical conditions.
04
Endpoints
Primary
Change in Hamilton Depression Rating Scale
Secondary
Glycated Hemoglobin
Patient Adherence
Neurocognitive and Neurobehavioral Symptoms
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