Omega-3 Supplementation to ADHD Medication in Children

Study Overview
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Brief Summary
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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.

Official Title
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A Pilot Study of Omega-3 Fatty Acid Supplementation to ADHD Medication in Children With ADHD and Deficits in Emotional Self-Regulation

Conditions
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Attention Deficit Hyperactivity Disorder, Deficient Emotional Self-Regulation

Intervention / Treatment
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* Dietary Supplement: Omega-3 Fatty Acid
* Drug: ADHD Medication


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omega-3 Fatty Acids and Stimulant Treatment<br>Participants will receive open-label treatment with Omega-3 Fatty Acids. All participants must also be treated with a stable dose of a traditional ADHD medication at the time of enrollment. | Dietary Supplement: Omega-3 Fatty Acid<br> <br> * Other names: Nordic Omega-3 Fishies;Drug: ADHD Medication<br> <br> * Other names: Tenex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emotional Control Subscale of the Behavior Rating Inventory of Executive Function - Parent Form (BRIEF-Parent) | The Behavior Rating Inventory of Executive Function - Parent Form (BRIEF-Parent) is a 75-item checklist with a large normative sample, internal consistency, test-retest reliability, inter-rater reliability, and external and concurrent validity, divided into nine empirically and theoretically derived and T-scored subscales. The Emotional Control subscale measures the impact of executive function problems on emotional expression and assesses a child's ability to modulate or control his or her emotional responses. It is a 10-item subscale, and each item is scored Never, Sometimes, or Often. Raw scores for all scales are computed with Software Portfolio (BRIEF-SP), which provides a raw score and T score (based on child's age) for each scale. Higher scores represent more greater emotional dysregulation. | Baseline and 12 Weeks | 
| Clinical Global Impression (CGI) Improvement for Deficient Emotional Self-Regulation (DESR) | The Clinical Global Impression (CGI) is a clinician rated measure of illness severity, improvement, and efficacy of treatment (collected at all study visits). We examined the CGI Improvement specifically. The CGI Improvement for Deficient Emotional Self-Regulation (DESR) was reported at baseline and completion. The CGI-I is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. It is rated as: Very much improved Much improved Minimally improved No change Minimally worse Much worse Very much worse | Baseline and 12 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD, Attention Deficit Hyperactivity Disorder, DESR, Deficient Emotional Self-Regulation, Emotional Dysregulation, Omega-3 Fatty Acids, Fish Oil