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Omega-3 as Monotherapy for Major Depression
NCT00238758Phase 2
Key facts
- Status
- Unknown
- Start
- Oct 2005
- Countries
- 1
- Sponsor
- University of New South Wales
- Modality
- Small Molecules
- Conditions
- major depressive disorder (MDD)persistent depressive disorder (PDD)
01
Overview
Phase 2, randomised, double-blind trial in major depressive disorder (MDD) and persistent depressive disorder (PDD) comparing Omega-3 with Placebo (2 arms). Primary endpoint: Change from pretreatment score on Depression Rating Scale at 6 weeks. Status: unknown.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Omega-3
Omega-3 (fish oil) for 6 weeks
Placebo
Placebo (paraffin oil) for 6 weeks
03
Who it enrols
Adults aged 21-65 with non-psychotic major depression or dysthymia, not currently taking antidepressants, with no history of psychosis, bipolar disorder, or recent substance abuse.
04
Endpoints
Primary
Change from pretreatment score on Depression Rating Scale
Secondary
Weekly measure of depressive symptoms
Weekly measure of anxiety symptoms
Weekly measure of functional status
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