Omega-3 Supplementation to ADHD Medication in Children

Completed · Phase 4

Conditions studied: Attention Deficit Hyperactivity Disorder, Deficient Emotional Self-Regulation

In brief

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.

Key facts

Study ID

NCT02204410

Run by

Massachusetts General Hospital

People needed

21

Starts

2014-07-01

Expected to finish

2016-08-01

Last updated by the study team

2017-06-29

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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