Omega-3 Supplementation to ADHD Medication in Children
Status: | Completed |
---|---|
Conditions: | Neurology, Psychiatric |
Therapuetic Areas: | Neurology, Psychiatry / Psychology |
Healthy: | No |
Age Range: | 6 - 17 |
Updated: | 12/22/2016 |
Start Date: | July 2014 |
End Date: | August 2016 |
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.
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
1
site
185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Timothy E. Wilens, MD
Phone: 617-724-5226
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