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OpenTrials
Completed

NCT Number: NCT03871088

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

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China Medical University Hospital

Taichung, 404, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omega-3 fatty acids

Dietary Supplement

12-week double-blind, randomized controlled trial

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

National Science and Technology Council, Taiwan

Other Gov

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Mar 12, 2019
Registry last updated
Mar 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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