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

China Medical University Hospital100 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

100

Conditions

ADHD Children Adolescents

Interventions

Omega-3DIETARY_SUPPLEMENT

EPA or DHA

PlaceboDIETARY_SUPPLEMENT

olive oil

Eligibility

Sex: ALLMin age: 6 YearsMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. DSM-5 diagnosis of ADHD 2. Did not have any changes of ADHD treatment (pharmacological/psychological) within 4 weeks of entering the trial. 3. SNAP-IV inattention subscale \>=12, or hyperactivity subscale \>=12, or inattention+ hyperactivity subscales \>=24 Exclusion Criteria: 1. IQ\<80 2. Allergic to omega-3 3. Physical disorders: thyroid function, cancer 4. Psychiatric comorbidity: SUD, psychotic disorders, bipolar disorder, major depressive disorder

Locations (1)

China Medical University Hospital

Taichung, Taiwan

RECRUITING

Outcomes

Primary Outcomes

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

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

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

Central Contacts

Pei-Chen Chang, PhD

CONTACT

+88622052121 013121@tool.caaumed.org.tw

Data from ClinicalTrials.gov

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