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NCT Number: NCT07364331

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

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.

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Key information

Conditions

ADHD Adolescents Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Children Mental Disorders Neurodevelopmental Disorders

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China Medical University Hospital

Taichung, 404, Taiwan

Location status: Recruiting

Location contact

Pei-Chen Chang, PhD

CONTACT

[email protected]

886 4 22052121

Pei-chen Chang, PD

PRINCIPAL_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Omega-3

Dietary Supplement

EPA or DHA

Placebo

Dietary Supplement

olive oil

Primary outcomes

  1. Clinical symptoms-attention and impulsivity symptom severity

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

    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.

Secondary outcomes

  1. Measurement of cognitive function: attention and impulsivity

    Time frame: week 0,12

    The Continuous Performance Test (CPT) will be used to measure attention and impulse control of the subjects. During the test, individuals are presented with a series of stimuli and must respond to specific targets while ignoring distractions. It is commonly used to assess attention deficits and impulsivity, key symptoms in ADHD.

  2. Concentration of Peripheral cortisol levels

    Time frame: week 0,12

    saliva and blood samples will be taken to assess peripheral cortisol levels. (micrograms/deciliter, μg/dL)

Study contacts

Contact information is provided by the study sponsor or research team.

Pei-Chen Chang, PhD

CONTACT

[email protected]

+88622052121 ext. 14126

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Registry information

Official study title

Omega- 3 Fatty Acids, Neuroendocrine and Attention Deficit Hyperactivity Disorder With (OMNeADHD) A Double Blind Randomized Controlled Trial of High Dose Omega- 3 Fatty Acids in Children and Adolescents With ADHD With Omega- 3 Deficiency.

Acronym: OMNeADHD

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jan 23, 2026
Registry last updated
Jan 26, 2026

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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