Phase 3
N=196
Safety and Effectiveness of Omega 3-Fatty Acids, EPA Versus DHA, for the Treatment of Major Depression
Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00361374 ↗Enrolled (actual)
196
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcome: Primary: Score on a Depression Severity Rating Scale Over Eight Weeks — -10.34; -9.26; -9.49 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- eicosapentaenoic acid (Dietary_supplement); docosahexaenoic acid (Dietary_supplement); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Feb 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Score on a Depression Severity Rating Scale Over Eight Weeks |
-10.34; -9.26; -9.49 | — |
Summary
This study examines the difference in the effectiveness of two natural compounds, eicosapentanoic (EPA) and docosahexanoic (DHA)omega-3 fatty acids, in treating major depressive disorder. Both types of omega-3 fatty acids are commonly found in fish oils. It is believed that a deficiency in these omega-3 fatty acids may lead to the development of major depression.
Eligibility Criteria
Inclusion Criteria
- Men or women aged 18-80 years old.
- Must meet criteria for current Major Depressive Disorder.
Exclusion Criteria
- Serious or unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic disease
- History of seizure disorder.
- Substance use disorders, including alcohol, active within the last six months (past history is OK).
- History of multiple adverse drug reactions or allergy to the study drugs.
Data sourced from ClinicalTrials.gov (NCT00361374). 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.