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

NCT03871088 | Completed DMC

• 1 other identifier: NHRI-EX105-10528NI
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Major Depressive Disorder

Keywords

Depression, omega-3 fatty acids, nutritional intervention

Outcome Measures

Primary Outcomes (1)

• Hamilton Rating Scale for Depression (HAMD) Changes

  The Changes of scores in Hamilton Rating Scale for Depression

  From Week 0 to Week 12

Secondary Outcomes (2)

• Response rate

  at Week 12

• Remission rate

  at Week 12

Study Arms (3)

Eicosapentaenoic acid (EPA)

ACTIVE COMPARATOR

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

Dietary Supplement: Omega-3 fatty acids

Docosahexaenoic acid (DHA)

EXPERIMENTAL

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

Dietary Supplement: Omega-3 fatty acids

EPA/DHA combination

ACTIVE COMPARATOR

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

Dietary Supplement: Omega-3 fatty acids

Interventions

Omega-3 fatty acids DIETARY_SUPPLEMENT

12-week double-blind, randomized controlled trial

Docosahexaenoic acid (DHA); EPA/DHA combination; Eicosapentaenoic acid (EPA)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• the diagnostic criteria of DSM-IV for MDD
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Science and Technology Council, Taiwan: lead

Study Sites (1)

China Medical University Hospital

Taichung, 404, Taiwan

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 7, 2019
• First Posted: March 12, 2019
• Study Start: July 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 12, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)