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Recruiting NCT07364331

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

No phase Interventional ADHD Children Adolescents

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Omega-3, Placebo.
Who it may be relevant to
Registry conditions: ADHD, Children, Adolescents. Basic parameters: 6 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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.

Overview

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.

Detailed description

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.

Interventions

  • Dietary supplement Omega-3
    EPA or DHA
  • Dietary supplement Placebo
    olive oil

Primary outcome measures

  • Clinical symptoms-attention and impulsivity symptom severity [Time frame: week 0,1,2,4,8,12]
Secondary outcome measures (2)
  • Measurement of cognitive function: attention and impulsivity [Time frame: week 0,12]
  • Concentration of Peripheral cortisol levels [Time frame: week 0,12]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • China Medical University Hospital — Taichung

Identifiers

NCT: NCT07364331 · CMUH110-REC3-203

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗