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Effexor XR in Elderly Depression
NCT00225485Phase 3
Key facts
- Status
- Completed
- Start
- Dec 2003
- Countries
- 1
- Sponsor
- Pfizer
- Modality
- Small Molecules
- Drugs
- venlafaxine
- Conditions
- major depressive disorder (MDD)
01
Overview
Phase 3, open-label, single-arm trial of venlafaxine in major depressive disorder (MDD), sponsored by Pfizer. Primary endpoint: Response rate of HAM-D17. Started Dec 2003; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Effexor XR
Single arm receiving Effexor XR
03
Who it enrols
Elderly patients (typically >= 60 years) diagnosed with major depression (DSM-IV-TR) with a HAM-D17 score >= 18. Excludes patients with schizophrenia, other psychotic disorders, or bipolar disorder.
04
Endpoints
Primary
Response rate of HAM-D17
Secondary
Difference of total score of HAM-D17 between baseline and final-on-therapy
Remission rate of HAM-D17
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