The Effect of Fish Oil in Major Depressive Disorder

The Effect of Fish Oil in Major Depressive Disorder: a Double-blind Placebo-controlled Monotherapy Trail and a RCT for Recurrence Prevention

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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Dietary supplement: Omega-3 fatty acids; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 404
    • China Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. DSM-IV criteria for major depressive disorder.
2. Age being age 18-65.
3. Capacity and willingness to give written informed consent.

Exclusion Criteria:

1. Any major medical illnesses.
2. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: omega-3 fatty acids; EPA 2.1 g/d+DHA 1.1 g/d	Dietary supplement: Omega-3 fatty acids; EPA 2.1 g/d+DHA 1.1 g/d
PLACEBO_COMPARATOR: Placebo; high oleic oil	Dietary supplement: Placebo; high oleic oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
HAMD	W0 W2 W4 W8 W12

Secondary Outcome Measures

Outcome Measure	Time Frame
BDI	W0 W2 W4 W8 W12
Adverse effects	W0 W2 W4 W8 W12
Recurrence rate	M0 M1 M2 M3 M4 M6

Collaborators and Investigators

• Sponsor: National Science Council, Taiwan

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Primary Completion (ACTUAL): January 1, 2014
• Study Completion (ACTUAL): December 1, 2014

Study Registration Dates

• First Submitted: December 31, 2008
• First Submitted That Met QC Criteria: December 31, 2008
• First Posted (ESTIMATE): January 1, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): April 14, 2015
• Last Update Submitted That Met QC Criteria: April 13, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: DMR93-IRB-87