Omega-3 Supplementation to ADHD Medication in Children

Conditions:Neurology, Psychiatric
Therapuetic Areas:Neurology, Psychiatry / Psychology
Age Range:6 - 17
Start Date:July 2014
End Date:August 2016

Use our guide to learn which trials are right for you!

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

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 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.

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
We found this trial at
185 Cambridge Street
Boston, Massachusetts 02114
Principal Investigator: Timothy E. Wilens, MD
Phone: 617-724-5226
Boston, MA
Click here to add this to my saved trials