N-3 Fatty Acids as the First-line Antidepressant Therapy: From Biomarkers to Clinical Subtypes

March 8, 2019 updated by: Kuan-Pin, National Science Council, Taiwan
Investigate the clinical subtypes and the biological markers to personalize the use n-3 PUFAs (EPA, DHA, and EPA/DHA) in MDD.

Study Overview

Status

Completed

Detailed Description

In this proposal, the investigators aim to explore the clinical subtypes and biological markers to personalize the use n-3 PUFAs (EPA, DHA, and EPA/DHA) in MDD. By stratifying the subjects with (versus without) remission and treatment response, the biological markers are expected to have important prediction effects in future clinical practice.

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Taichung, Taiwan, 404
        • China Medical University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • the diagnostic criteria of DSM-IV for MDD
  • 18 to 65 years old
  • pre-study ratings of 18 or greater on the 21-item Hamilton Rating Scale for Depression (HAMD)
  • physically healthy under comprehensive evaluations in medical history, physical examination, and laboratory parameters tests
  • have not received any psychiatric treatment in 2 weeks
  • competent to receive a full explanation of this study and give written informed consent.

Exclusion Criteria:

  • a recent or past history of other DSM-IV AxisI diagnoses besides unipolar major depression, including psychotic disorders, organic mental disorders, impulse control disorders, substance use disorder or substance abuse (last 6 months prior to the study), and bipolar disorders
  • AxisII diagnoses, including borderline and antisocial personality disorder
  • a notable medical comorbidity
  • acutely suicidal ideation and attempt were noted that close monitoring such as hospitalization is necessary
  • regular consumption of omega-3 PUFAs supplements or a habit of eating fish equal or more than 4 times per week

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Eicosapentaenoic acid (EPA)
Eicosapentaenoic acid (EPA) is an omega-3 fatty acid. In physiological literature, it is given the name 20:5(n-3).
12-week double-blind, randomized controlled trial
Experimental: Docosahexaenoic acid (DHA)
Docosahexaenoic acid (DHA) is an omega-3 fatty acid. In physiological literature, it is given the name 22:6(n-3).
12-week double-blind, randomized controlled trial
Active Comparator: EPA/DHA combination
EPA/DHA means the combination of omega-3 fatty acids Eicosapentaenoic and Docosahexaenoic acids.
12-week double-blind, randomized controlled trial

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hamilton Rating Scale for Depression (HAMD) Changes
Time Frame: From Week 0 to Week 12
The Changes of scores in Hamilton Rating Scale for Depression
From Week 0 to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate
Time Frame: at Week 12
50% decreases in the Hamilton Rating Scale for Depression from W0 to W12
at Week 12
Remission rate
Time Frame: at Week 12
Less than 8 points in the Hamilton Rating Scale for Depression at W12
at Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

March 7, 2019

First Submitted That Met QC Criteria

March 8, 2019

First Posted (Actual)

March 12, 2019

Study Record Updates

Last Update Posted (Actual)

March 12, 2019

Last Update Submitted That Met QC Criteria

March 8, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • NHRI-EX105-10528NI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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