This trial has been completed.

Conditions attention deficit hyperactivity disorder, deficient emotional self-regulation
Treatments omega-3 fatty acid, adhd medication
Phase phase 4
Sponsor Massachusetts General Hospital
Start date July 2014
End date May 2016
Trial size 21 participants
Trial identifier NCT02204410, 2014-P-000015


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
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.
omega-3 fatty acid Fish Oil
adhd medication Stimulant

Primary Outcomes

Behavior Rating Inventory of Executive Function- Parent Form Emotional Control Subscale
time frame: 12 Weeks

Eligibility Criteria

Male or female participants from 6 years up to 17 years old.

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

Additional Information

Official title A Pilot Study of Omega-3 Fatty Acid Supplementation to ADHD Medication in Children With ADHD and Deficits in Emotional Self-Regulation
Principal investigator Timothy E. Wilens, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.