Adhd
Conditions
Keywords
children, inflammation, omega-3
Brief summary
This is a 12 week study to investigate the effects of omega-3 polyunsaturated fatty acids (PUFAs) in children with attention deficit hyperactivity disorder (ADHD).
Detailed description
This is a 12 week study to investigate the effects of omega-3 PUFAs in children (6-12 years-old) with ADHD. The primary outcome will be the clinical symptoms The secondary outcomes will be inflammatory biomarkers, cognitive function and physiological markers such as heart-rate variability.
Interventions
DIETARY_SUPPLEMENTOmega-3
Omega-3 PUFAs
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
To investigate the effects of DHA, EPA and placebo in children and adolescents with ADHD
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of ADHD (DSM-5) made by a child and adolescent psychiatrist. * Age range: 6-12 years old at the time of enrollment. * SNAP-IV (Mandarin Chinese Version): Inattention subscale score \> 12 or Hyperactivity/impulsivity subscale score \> 12 or Total score \> 24 * Drug-naïve or no ADHD medication use in the past 6 months. * Signed informed consent required.
Exclusion criteria
* Intelligence quotient \<80 * Comorbid other psychiatric disorders, such as autism spectrum disorder, anxiety disorder, conduct disorder, schizophrenia, mood disorder * Comorbid physical disorders, such as thyroid dysfunction, cerebral palsy, coagulation disorders * Currently using omega-3 supplements * Allergy to omega-3
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Symptoms-Swanson, Nolan, and Pelham Rating Scale-4th Edition(SNAP-IV) | Baseline, week 1,2,4,8,12 | The SNAP-IV is used 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 |
|---|---|---|
| Cognitive function-Continuous Performance Test (CPT) | Baseline and week 12 | CPT is used to assess attention and impulsivity in the subjects. It involves presenting a series of stimuli (usually letters or numbers) on a screen, where the participant must respond to certain targets and ignore others, assessing their ability to sustain attention over time and control impulses. The test helps identify attention deficits, impulsivity, and response inhibition, key areas impacted in ADHD. |
| Concentration of Peripheral Inflammatory Biomarkers | Baseline and week 12 | high-sensitivty C-reactive protein (hs-CRP) (milligram/Liter, mg/L) Interleukin (IL)-6 (picogram/milliliter, pg/mL) |
Countries
Taiwan
Contacts
PRINCIPAL_INVESTIGATORPei-Chen Chang, MD, PhD
China Medical University Hospital
Outcome results
None listed