Omega-3 Supplementation to ADHD Medication in Children


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 stimulants in children and adolescents with Attention Deficit/Hyperactivity Disorder. Subjects will be between the ages of 6-17 and will currently be on traditional stimulant medication for their Attention Deficit/Hyperactivity Disorder but still experience DESR traits.

Study Start Date

July 2014

Estimated Completion Date

December 2016


  • Drug: Stimulant Medication
  • Dietary Supplement: Omega-3 Fatty Acid


  • Nursing: Mental Health
  • Pediatrics: Child/Adolescent Psych
  • Psychiatry: Child/Adolescent Psych
  • Family Medicine: Preventive/Nutrition,Psychiatry
  • Nurse Practitioner: Mental Health,Nutrition

MeSH Terms

  • Attention Deficit Disorder with Hyperactivity
  • Omega-3 Fatty Acid

Study ID

Massachusetts General Hospital -- 2014-P-000015



Trial ID


Study Type


Trial Phase

Phase 4

Enrollment Quota



Massachusetts General Hospital

Inclusion Criteria

  • Male and female children Ages 6-17 (and at least one parent)
  • Lives at Home
  • Diagnosis of ADHD based on the Diagnostic and Statistical Manual
  • Fourth Edition (DSM-IV), per clinical evaluation
  • Has a score outside the normal range (a T-score of 65 or greater) on the Emotional Control subscale of the Behavior Rating Inventory of Executive Function parent-report version (BRIEF-P)
  • Currently on an FDA-approved stimulant medication to treat ADHD for at least one month
  • Able to swallow pills
  • Able to come to weekly/monthly study visits for 12 weeks
  • Has a parent or guardian with a level of understanding of the study

Exclusion Criteria

  • Has an unstable medical illness as determined by the clinician investigator
  • Has a current diagnosis of schizophrenia or bipolar disorder
  • Has delusions or hallucinations
  • Has a bleeding disorder
  • Takes any other ongoing non-ADHD psychotropic medications, other than stable, effective dose of a serotonin re-uptake inhibitor (SSRI) such as fluoxetine (Prozac), citalopram (Celexa), or medications used on an as-needed basis
  • Pregnant or nursing females
  • Intelligence Quotient (IQ) less than 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
  • Allergies to fish or shellfish or omega-3 fish oils
  • multiple adverse drug reactions
  • Unwilling/unable to comply with study procedures
  • Poor command of the English language




6 Years to 17 Years

Accepts Healthy Volunteers


Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Nicholas Carrellas BA 617-724-5226 provides clinical trial listings in an easy to view format. All clinical trial information is pulled directly from This website does not guarantee acceptance into any clinical trial, and is not responsible for adverse events that may be incurred from a clinical trial.