Status:
COMPLETED
Omega-3 Supplementation to ADHD Medication in Children
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Attention Deficit Hyperactivity Disorder
Deficient Emotional Self-Regulation
Eligibility:
All Genders
6-17 years
Phase:
PHASE4
Brief Summary
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 Attention Deficit/Hyperactivity Disorder (...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT02204410
Start Date
July 1 2014
End Date
August 1 2016
Last Update
June 29 2017
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114