Phase 3
N=20
Omega-3 Fatty Acids as Adjunct Treatment for Major Depressive Disorder
Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00511810 ↗Enrolled (actual)
20
Serious AEs
10.0%
Results posted
Dec 2014
Primary outcome: Primary: Mood Symptoms Ratings — 33.0; 33.1 CDRS-R score
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Low Dose Fish Oil (Drug); High Dose Fish Oil (Drug)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- University of Cincinnati
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mood Symptoms Ratings |
33.0; 33.1 | — |
Summary
The primary objective of the study was to determine the effects of 10-week adjunctive supplementation with 2 doses of LCn-3 fatty acids (fish oil) on cortical functional activity and biochemistry in adolescents with MDD.
The primary prediction was that LCn-3 fatty acid supplementation would dose-dependently increase prefrontal cortical functional activation during sustained attention and increase regional biochemical indices of cortical metabolism and integrity concentrations in association with reductions in depressive symptoms.
Eligibility Criteria
Inclusion Criterion:
- Between the ages of 12-18 years.
- Diagnosis of MDD and not exhibited symptom remission CDRS-R (> 28 but 3).
- Hospitalized within the last 3 months
- Greater than 1 year outside appropriate age/grade level
- Pacemaker
- Cerebral aneurysm clip
- Cochlear implant
- Metal fragments lodged within the eye or braces
- Claustrophobia
- Necessity of sedation (no sedation will be given).
- History of loss of consciousness > 10 minutes in duration
- Allergy to seafood.
Data sourced from ClinicalTrials.gov (NCT00511810). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.