Phase 4
Completed N=21
Omega-3 Supplementation to ADHD Medication in Children
Attention Deficit Hyperactivity Disorder · Deficient Emotional Self-Regulation
Source: ClinicalTrials.gov NCT02204410 ↗
Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcomePrimary: Emotional Control Subscale of the Behavior Rating Inventory of Executive Function - Parent Form (BRIEF-Parent) — 65.3; 58.4 units on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This study is a 12-week open-label trial to assess the effectiveness of Omega-3 fatty acids for deficient emotional self-regulation (DESR) as a supplement to Attention Deficit/Hyperactivity Disorder (ADHD) treatment in children and adolescents with Attention Deficit/Hyperactivity Disorder. Subjects will be between the ages of 6-17 and will currently be on medication for their Attention Deficit/Hyperactivity Disorder but still experience DESR traits.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Emotional Control Subscale of the Behavior Rating Inventory of Executive Function - Parent Form (BRIEF-Parent) |
65.3; 58.4 | — |
| PRIMARY Clinical Global Impression (CGI) Improvement for Deficient Emotional Self-Regulation (DESR) |
4.6; 3.0 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female children ages 6-17 years
- Living at home
- A diagnosis of ADHD (inattentive, hyperactive/impulsive, or combined type) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) based on clinical assessment
- Having a score outside the normal (a T-score of 60 or greater) on the Emotional Control subscale of the Behavior Rating Inventory of Executive Function (parent-report version) or a score outside the normal range (cumulative of 180 or greater) on the Anxious/Depressed, Attention Problems, and Aggressive Behavior subscales of the Child Behavior Checklist for ages (6-18)
- Currently on FDA approved traditional stimulant medication (such as Concerta of Adderall XR) or non-stimulant medication (such as Strattera or Tenex) for their ADHD for at least one month
- Beings able to come to weekly/monthly study visits for 12 weeks
- Having a parent or guardian with a level of understanding of the study
Exclusion Criteria
- Having unstable medical illness as determined by the clinician investigator
- Having a current diagnosis of schizophrenia or bipolar disorder
- Having delusions or hallucinations
- Having a bleeding disorder
- Taking any other ongoing non-ADHD psychotropic medications other than stable, effective serotonin reuptake inhibitors such as fluoxetine (Prozac), citalopram (Celexa) or medications used on an as-needed basis
- Pregnant or nursing females
- IQ < 70 by previous testing or as judged by the clinician investigator
- Illegal substance use
- Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild
- Presence of suicidal risk, or homicidality
- Unwilling/unable to comply with study procedures
- Allergies to fish or shellfish or omega 3 fish oils; multiple adverse drug reactions
- Poor command of the English language
Data sourced from ClinicalTrials.gov (NCT02204410). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.