Omega-3 Supplementation to ADHD Medication in Children

Mass General Brigham

Status and phase: Completed; Phase 4

Conditions: Deficient Emotional Self-Regulation; Attention Deficit Hyperactivity Disorder

Treatments: Dietary Supplement: Omega-3 Fatty Acid; Drug: ADHD Medication

Study type: Interventional

Funder types: Other

Identifiers

NCT02204410

2014-P-000015

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Omega-3 Fatty Acids and Stimulant Treatment

Experimental group

Description:

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.

Treatment:

Drug: ADHD Medication

Dietary Supplement: Omega-3 Fatty Acid