The Effect of Fish Oil in Major Depressive Disorder
1 other identifier
interventional
120
1 country
1
Brief Summary
The whole study was divided into two major parts: (A) the 12-week, double-blind, randomized controlled, parallel omega-3 fatty acid monotherapy study in 60 patients with mild to moderate major depressive disorder. (B) The double-blind, randomized controlled, parallel omega-3 fatty acid add-on prevention study in 60 patients with major depressive disorder in recovery status. The goals of this study were to examine the therapeutic and recurrence prevention effects of omega-3 fatty acids on major depressive disorder.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable major-depressive-disorder
Started Jan 2005
Longer than P75 for not_applicable major-depressive-disorder
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 31, 2008
CompletedFirst Posted
Study publicly available on registry
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedApril 14, 2015
April 1, 2015
9 years
December 31, 2008
April 13, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
HAMD
W0 W2 W4 W8 W12
Secondary Outcomes (3)
BDI
W0 W2 W4 W8 W12
Adverse effects
W0 W2 W4 W8 W12
Recurrence rate
M0 M1 M2 M3 M4 M6
Study Arms (2)
omega-3 fatty acids
ACTIVE COMPARATOREPA 2.1 g/d+DHA 1.1 g/d
Placebo
PLACEBO COMPARATORhigh oleic oil
Interventions
Eligibility Criteria
You may qualify if:
- DSM-IV criteria for major depressive disorder.
- Age being age 18-65.
- Capacity and willingness to give written informed consent.
You may not qualify if:
- Any major medical illnesses.
- A recent or past history of any Axis-I diagnoses besides major depressive disorder, including psychotic disorders; cognitively impaired mental disorders; impulse control disorders; substance use disorder or substance abuse (last 6 months prior to the studies); primary anxiety disorders, including post-traumatic stress disorder and panic disorder; and bipolar disorders; or Axis-II diagnoses, i.e. borderline and antisocial personality disorder.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
China Medical University
Taichung, Taichung, 404, Taiwan
Related Publications (1)
Appleton KM, Voyias PD, Sallis HM, Dawson S, Ness AR, Churchill R, Perry R. Omega-3 fatty acids for depression in adults. Cochrane Database Syst Rev. 2021 Nov 24;11(11):CD004692. doi: 10.1002/14651858.CD004692.pub5.
PMID: 34817851DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Researcher
Study Record Dates
First Submitted
December 31, 2008
First Posted
January 1, 2009
Study Start
January 1, 2005
Primary Completion
January 1, 2014
Study Completion
December 1, 2014
Last Updated
April 14, 2015
Record last verified: 2015-04