Omega-3 Supplementation to ADHD Medication in Children

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: Adderall; Amphetamine; Central Nervous System Stimulants; Dextroamphetamine; Methylphenidate

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