The Effect of Fish Oil in Major Depressive Disorder | NCT00816322

Studies
The Effect of Fish Oil in Major Depressive Disorder

NCT00816322

Sponsor

National Science and Technology Council, Taiwan

Status

Completed

Last Update Posted

Apr 14, 2015Estimated

Enrollment

120Actual

Phase

Not Applicable

Conditions

Major Depressive Disorder

Interventions

Omega-3 fatty acids
Placebo

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2005

Primary Completion Date

Jan 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Dec 31, 2008

First Submission Date that Met QC Criteria

Dec 31, 2008

First Posted Date

Jan 1, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 13, 2015

Last Update Posted Date

Apr 14, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kuan-Pin, Researcher, National Science and Technology Council, TaiwanPrincipal Investigator

Lead Sponsor

National Science and Technology Council, TaiwanOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
omega-3 fatty acids	Active Comparator	EPA 2.1 g/d+DHA 1.1 g/d	Dietary Supplement: Omega-3 fatty acids
Placebo	Placebo Comparator	high oleic oil	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Omega-3 fatty acids	Dietary Supplement	EPA 2.1 g/d+DHA 1.1 g/d	omega-3 fatty acids

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HAMD		W0 W2 W4 W8 W12

Secondary Outcomes

Measure	Description	Time Frame
BDI		W0 W2 W4 W8 W12
Adverse effects		W0 W2 W4 W8 W12
Recurrence rate

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
China Medical University		Taichung	Taichung	404	Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34817851	Derived	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.

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders

ID	Term
D004042	Dietary Fats, Unsaturated
D004041	Dietary Fats
D005223	Fats
D008055	Lipids