- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03871088
N-3 Fatty Acids as the First-line Antidepressant Therapy: From Biomarkers to Clinical Subtypes
March 8, 2019 updated by: Kuan-Pin, National Science Council, Taiwan
Investigate the clinical subtypes and the biological markers to personalize the use n-3 PUFAs (EPA, DHA, and EPA/DHA) in MDD.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
400
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Taichung, Taiwan, 404
- China Medical University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / 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).
|
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).
|
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.
|
12-week double-blind, randomized controlled trial
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hamilton Rating Scale for Depression (HAMD) Changes
Time Frame: From Week 0 to Week 12
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The Changes of scores in Hamilton Rating Scale for Depression
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From Week 0 to Week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response rate
Time Frame: at Week 12
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50% decreases in the Hamilton Rating Scale for Depression from W0 to W12
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at Week 12
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Remission rate
Time Frame: at Week 12
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Less than 8 points in the Hamilton Rating Scale for Depression at W12
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at Week 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2015
Primary Completion (Actual)
June 1, 2018
Study Completion (Actual)
December 1, 2018
Study Registration Dates
First Submitted
March 7, 2019
First Submitted That Met QC Criteria
March 8, 2019
First Posted (Actual)
March 12, 2019
Study Record Updates
Last Update Posted (Actual)
March 12, 2019
Last Update Submitted That Met QC Criteria
March 8, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NHRI-EX105-10528NI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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