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

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ClinicalTrials.gov Identifier: NCT03871088
Recruitment Status : Completed
First Posted : March 12, 2019
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
Kuan-Pin, National Science Council, Taiwan

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

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Dietary Supplement: Omega-3 fatty acids Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: N-3 Fatty Acids as the First-line Antidepressant Therapy: From Biomarkers to Clinical Subtypes
Actual Study Start Date : July 2015
Actual Primary Completion Date : June 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants

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).
Dietary Supplement: Omega-3 fatty acids
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).
Dietary Supplement: Omega-3 fatty acids
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.
Dietary Supplement: Omega-3 fatty acids
12-week double-blind, randomized controlled trial




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Response rate [ Time Frame: at Week 12 ]
    50% decreases in the Hamilton Rating Scale for Depression from W0 to W12

  2. Remission rate [ Time Frame: at Week 12 ]
    Less than 8 points in the Hamilton Rating Scale for Depression at W12



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03871088


Locations
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Taiwan
China Medical University Hospital
Taichung, Taiwan, 404
Sponsors and Collaborators
National Science Council, Taiwan

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Responsible Party: Kuan-Pin, Professor, National Science Council, Taiwan
ClinicalTrials.gov Identifier: NCT03871088     History of Changes
Other Study ID Numbers: NHRI-EX105-10528NI
First Posted: March 12, 2019    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kuan-Pin, National Science Council, Taiwan:
Depression, omega-3 fatty acids, nutritional intervention

Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Psychotropic Drugs