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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03871088
• Other study ID #: NHRI-EX105-10528NI
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: December 2018

Study information

• Verified date: March 2019
• Source: National Science Council, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 ?sh equal or more than 4 times per week

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Rating Scale for Depression (HAMD) Changes	The Changes of scores in Hamilton Rating Scale for Depression	From Week 0 to Week 12
Secondary	Response rate	50% decreases in the Hamilton Rating Scale for Depression from W0 to W12	at Week 12
Secondary	Remission rate	Less than 8 points in the Hamilton Rating Scale for Depression at W12	at Week 12