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PUFA Augmentation in Major Depression
NCT00067301Phase 3
Key facts
- Status
- Completed
- Start
- Sep 2003
- Primary completion
- Apr 2007
- Countries
- 1
- Sponsor
- National Center for Complementary and Integrative Health
- Modality
- Small Molecules
- Conditions
- major depressive disorder (MDD)
01
Overview
Phase 3, randomised, double-blind trial in major depressive disorder (MDD) comparing EPA + Citalopram with Placebo + Citalopram (2 arms). Primary endpoints: Hamilton Depression Rating Scale (17 item) at 8 weeks and Structured Clinical Interview for DSM-IV Mood Module at 8 weeks. Started Sep 2003; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
EPA + Citalopram
Citalopram + ProEPA (eicosapentaenoic acid)
Placebo + Citalopram
Citalopram + Placebo EPA
03
Who it enrols
Adults with DSM-IV Major Depression and HAM-D > 17, excluding those with bipolar/psychotic disorders, substance abuse, or prior failure of citalopram.
04
Endpoints
Primary
Hamilton Depression Rating Scale (17 item)
Structured Clinical Interview for DSM-IV Mood Module
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