Health TrialsbyHealthPanel

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

ConditionsADHDChildrenAdolescents
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-18
SponsorChina Medical University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

IQ<80

Allergic to omega-3

Physical disorders: thyroid function, cancer

Psychiatric comorbidity: SUD, psychotic disorders, bipolar disorder, major depressive disorder

Trial design

Design model

Parallel

Treatments tested in this trial

  • Omega-3

    Dietary supplement

    EPA or DHA

  • Placebo

    Dietary supplement

    olive oil

Treatment groups

100 Participants
are divided into 3 treatment groups
Group A: omega-3 fatty acids: EPAActive comparator 1 intervention
Group B: omega-3 fatty acids: DHAActive comparator 1 intervention
Group C: placeboPlacebo comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Measurement of cognitive function: attention and impulsivity

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.

Time frame
week 0,12
2

Concentration of Peripheral cortisol levels

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

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
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