Back to resultsThe Effect of Fish Oil in Major Depressive Disorder
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Omega-3 fatty acids
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Major Depressive Disorder
Eligibility Criteria
Inclusion Criteria:
- DSM-IV criteria for major depressive disorder.
- Age being age 18-65.
- Capacity and willingness to give written informed consent.
Exclusion Criteria:
- 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.
Sites / Locations
- China Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
omega-3 fatty acids
Placebo
Arm Description
EPA 2.1 g/d+DHA 1.1 g/d
high oleic oil
Outcomes
Primary Outcome Measures
HAMD
Secondary Outcome Measures
BDI
Adverse effects
Recurrence rate
Full Information
NCT ID
NCT00816322
First Posted
December 31, 2008
Last Updated
April 13, 2015
Sponsor
National Science Council, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT00816322
Brief Title
The Effect of Fish Oil in Major Depressive Disorder
Official Title
The Effect of Fish Oil in Major Depressive Disorder: a Double-blind Placebo-controlled Monotherapy Trail and a RCT for Recurrence Prevention
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Science Council, Taiwan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
omega-3 fatty acids
Arm Type
Active Comparator
Arm Description
EPA 2.1 g/d+DHA 1.1 g/d
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
high oleic oil
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3 fatty acids
Intervention Description
EPA 2.1 g/d+DHA 1.1 g/d
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
high oleic oil
Primary Outcome Measure Information:
Title
HAMD
Time Frame
W0 W2 W4 W8 W12
Secondary Outcome Measure Information:
Title
BDI
Time Frame
W0 W2 W4 W8 W12
Title
Adverse effects
Time Frame
W0 W2 W4 W8 W12
Title
Recurrence rate
Time Frame
M0 M1 M2 M3 M4 M6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
DSM-IV criteria for major depressive disorder.
Age being age 18-65.
Capacity and willingness to give written informed consent.
Exclusion Criteria:
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.
Facility Information:
Facility Name
China Medical University
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
34817851
Citation
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.
Results Reference
derived
Learn more about this trial
The Effect of Fish Oil in Major Depressive Disorder
We'll reach out to this number within 24 hrs