Health TrialsbyHealthPanel

Omega-3 Fatty Acids, Inflammation, Gut Microbiota in Youth With Depression

ConditionADHD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-18
SponsorChina Medical University Hospital

About this trial

This is a 12 week double blind RCT aimed to investigate the role of omega-3 fatty acids in patients with major depressive disorder

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Youth with a DSM-5 diagnosis of MDE

Disqualifiers

Has a recent change in antidepressants or psychotherapy treatment within 4 weeks.

Allergic to omega-3 fatty acids

Trial design

Design model

Parallel

Treatments tested in this trial

  • Omega-3 fatty acids

    Combination product

    omega-3 fatty acids (EPA)

  • Placebo

    Dietary supplement

    soy bean oil

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: omega-3Active comparator 1 intervention
Group B: placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

clinical symptoms

Hamilton Depression Rating Scale (HAMD)-21 item is a clinician-rated scale designed to assess the severity of depressive symptoms over the past week. It is commonly used in clinical trials and psychiatric practice Total Score Interpretation (Commonly Used) Total Score and Severity Level * 0-7: No depression / Normal * 8-13: Mild depression * 14-18: Moderate depression * 19-22: Severe depression -≥23: Very severe depression

Time frame
week 0,1,2,4,8,12

Secondary outcomes

1

gut microbiota

gut microbiota

Time frame
week 0,12
2

inflammatory cytokines (IL-6, hsCRP)

blood inflammatory cytokines

Time frame
week 0,12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

China Medical University Hospital

Lead sponsor

Source ClinicalTrials.gov
Apply now