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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Omega-3 fatty acids
Sponsored by
National Science Council, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Major Depressive Disorder focused on measuring Depression, omega-3 fatty acids, nutritional intervention

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • China Medical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Active Comparator

Arm Label

Eicosapentaenoic acid (EPA)

Docosahexaenoic acid (DHA)

EPA/DHA combination

Arm Description

Eicosapentaenoic acid (EPA) is an omega-3 fatty acid. In physiological literature, it is given the name 20:5(n-3).

Docosahexaenoic acid (DHA) is an omega-3 fatty acid. In physiological literature, it is given the name 22:6(n-3).

EPA/DHA means the combination of omega-3 fatty acids Eicosapentaenoic and Docosahexaenoic acids.

Outcomes

Primary Outcome Measures

Hamilton Rating Scale for Depression (HAMD) Changes
The Changes of scores in Hamilton Rating Scale for Depression

Secondary Outcome Measures

Response rate
50% decreases in the Hamilton Rating Scale for Depression from W0 to W12
Remission rate
Less than 8 points in the Hamilton Rating Scale for Depression at W12

Full Information

First Posted
March 7, 2019
Last Updated
March 8, 2019
Sponsor
National Science Council, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT03871088
Brief Title
N-3 Fatty Acids as the First-line Antidepressant Therapy: From Biomarkers to Clinical Subtypes
Official Title
N-3 Fatty Acids as the First-line Antidepressant Therapy: From Biomarkers to Clinical Subtypes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
July 2015 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Science Council, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Investigate the clinical subtypes and the biological markers to personalize the use n-3 PUFAs (EPA, DHA, and EPA/DHA) in MDD.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Depression, omega-3 fatty acids, nutritional intervention

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Eicosapentaenoic acid (EPA)
Arm Type
Active Comparator
Arm Description
Eicosapentaenoic acid (EPA) is an omega-3 fatty acid. In physiological literature, it is given the name 20:5(n-3).
Arm Title
Docosahexaenoic acid (DHA)
Arm Type
Experimental
Arm Description
Docosahexaenoic acid (DHA) is an omega-3 fatty acid. In physiological literature, it is given the name 22:6(n-3).
Arm Title
EPA/DHA combination
Arm Type
Active Comparator
Arm Description
EPA/DHA means the combination of omega-3 fatty acids Eicosapentaenoic and Docosahexaenoic acids.
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3 fatty acids
Intervention Description
12-week double-blind, randomized controlled trial
Primary Outcome Measure Information:
Title
Hamilton Rating Scale for Depression (HAMD) Changes
Description
The Changes of scores in Hamilton Rating Scale for Depression
Time Frame
From Week 0 to Week 12
Secondary Outcome Measure Information:
Title
Response rate
Description
50% decreases in the Hamilton Rating Scale for Depression from W0 to W12
Time Frame
at Week 12
Title
Remission rate
Description
Less than 8 points in the Hamilton Rating Scale for Depression at W12
Time Frame
at Week 12

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: 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
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
404
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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

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