ADHD, Adolescents, Children
Conditions
Keywords
omega-3, epa, dha, children, ADHD, adolescents
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.
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_SUPPLEMENTOmega-3
EPA or DHA
DIETARY_SUPPLEMENTPlacebo
olive oil
Sponsors
China Medical University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
double blind
Intervention model description
This is a 12 week study to investigate the effects of EPA, DHA and placebo in youth with ADHD
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical symptoms-attention and impulsivity symptom severity | 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
| Measure | Time frame | Description |
|---|---|---|
| Measurement of cognitive function: attention and impulsivity | 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. |
| Concentration of Peripheral cortisol levels | week 0,12 | saliva and blood samples will be taken to assess peripheral cortisol levels. (micrograms/deciliter, μg/dL) |
Countries
Taiwan
Contacts
CONTACTPei-Chen Chang, PhD
PRINCIPAL_INVESTIGATORPei-Chen Chang, PhD
China Medical University Hospital
Outcome results
None listed