Omega-3 Fatty Acids, Neuroendocrine and Attention Deficit Hyperactivity Disorder (OMNeADHD)

NCT07364331 | Recruiting

• 1 other identifier: CMUH110-REC3-203
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This is a 12 week randomized controlled study on the effects of omega-3 fatty acids in youth with attention deficit hyperactivity disorder (ADHD) with omega-3 deficiency.

Conditions

ADHD; Children; Adolescents

Keywords

omega-3; epa; dha; children; ADHD; adolescents

Outcome Measures

Primary Outcomes (1)

• Clinical symptoms-attention and impulsivity symptom severity

  The Swanson, Nolan, and Pelham Rating Scale- 4th edition (SNAP-IV) is used to help assess symptoms of ADHD (Attention Deficit Hyperactivity Disorder) in children and adolescents. It consists of a series of questions that rate the severity of behaviors such as inattention, hyperactivity, and impulsivity, based on teacher and parent observations. The scale includes both parent and teacher versions, allowing for a comprehensive view of a child's behavior in different environments. The scoring system rates each behavior on a 4-point scale from 0 (never or rarely) to 3 (very often), and higher total scores indicate more significant ADHD symptoms. The results help clinicians in diagnosing ADHD and monitoring treatment progress.

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

Secondary Outcomes (2)

• Measurement of cognitive function: attention and impulsivity

  week 0,12

• Concentration of Peripheral cortisol levels

  week 0,12

Study Arms (3)

omega-3 fatty acids: EPA

ACTIVE COMPARATOR

EPA

Dietary Supplement: Omega-3

omega-3 fatty acids: DHA

ACTIVE COMPARATOR

DHA

Dietary Supplement: Omega-3

placebo

PLACEBO COMPARATOR

olive oil

Dietary Supplement: Placebo

Interventions

Omega-3 DIETARY_SUPPLEMENT

EPA or DHA

omega-3 fatty acids: DHA; omega-3 fatty acids: EPA

Placebo DIETARY_SUPPLEMENT

olive oil

placebo

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• DSM-5 diagnosis of ADHD
• Did not have any changes of ADHD treatment (pharmacological/psychological) within 4 weeks of entering the trial.
• SNAP-IV inattention subscale \>=12, or hyperactivity subscale \>=12, or inattention+ hyperactivity subscales \>=24

You may not qualify if:

• IQ\<80
• Allergic to omega-3
• Physical disorders: thyroid function, cancer
• Psychiatric comorbidity: SUD, psychotic disorders, bipolar disorder, major depressive disorder

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, 404, Taiwan

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Pei-Chen Chang, PhD

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pei-Chen Chang, PhD

CONTACT

+88622052121; 013121@tool.caaumed.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Child Psychiatry Division

Model Details: This is a 12 week study to investigate the effects of EPA, DHA and placebo in youth with ADHD

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: January 23, 2026
• Study Start: September 4, 2021
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)