Omega-3 Supplementation to ADHD Medication in Children

Description

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

Interventions

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

Specialties

  • 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

Status

Unknown

Trial ID

NCT02204410

Study Type

Interventional

Trial Phase

Phase 4

Enrollment Quota

20

Sponsor

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

Gender

Both

Ages

6 Years to 17 Years

Accepts Healthy Volunteers

No

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 ncarrellas@mgh.harvard.edu

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