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
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Clinical symptoms-attention and impulsivity symptom severity
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
double blind
Eligibility Criteria
- Ages
- 6 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Allergic to omega-3
- •Physical disorders: thyroid function, cancer
- •Psychiatric comorbidity: SUD, psychotic disorders, bipolar disorder, major depressive disorder
Arms & Interventions
omega-3 fatty acids: EPA
EPA
Intervention: Omega-3 (Dietary Supplement)
omega-3 fatty acids: DHA
DHA
Intervention: Omega-3 (Dietary Supplement)
placebo
olive oil
Intervention: Placebo (Dietary Supplement)
Outcomes
Primary Outcomes
Clinical symptoms-attention and impulsivity symptom severity
Time Frame: 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 Outcomes
- Measurement of cognitive function: attention and impulsivity(week 0,12)
- Concentration of Peripheral cortisol levels(week 0,12)
Investigators
Pei-Chen Chang
Director of Child Psychiatry Division
China Medical University Hospital