Omega-3 Supplementation to ADHD Medication in Children

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

A Pilot Study of Omega-3 Fatty Acid Supplementation to ADHD Medication in Children With ADHD and Deficits in Emotional Self-Regulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02204410
• Other study ID #: 2014-P-000015
• Status: Completed
• Phase: Phase 4
• First received: July 28, 2014
• Last updated: December 20, 2016
• Start date: July 2014
• Est. completion date: August 2016

Study information

• Verified date: December 2016
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: August 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 17 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Deficient Emotional Self-Regulation
• Hyperkinesis

Intervention

Dietary Supplement:
• Omega-3 Fatty Acid

Drug:
• ADHD Medication

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Behavior Rating Inventory of Executive Function- Parent Form Emotional Control Subscale	This is a 75-item checklist with a large normative sample, internal consistency, test-retest reliability, inter-rater reliability, and external and concurrent validity, divided into nine empirically and theoretically derived and T-scored subscales, including the Emotional Control subscale.	12 Weeks	No