Omega-3 Supplementation to ADHD Medication in Children

NCT ID: NCT02204410

Last Updated: 2017-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2016-08-31

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 (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.

Conditions

Attention Deficit Hyperactivity Disorder; Deficient Emotional Self-Regulation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Omega-3 Fatty Acids and Stimulant 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.

Group Type: EXPERIMENTAL

Omega-3 Fatty Acid

Intervention Type: DIETARY_SUPPLEMENT

ADHD Medication

Intervention Type: DRUG

Interventions

Omega-3 Fatty Acid

Intervention Type: DIETARY_SUPPLEMENT

ADHD Medication

Intervention Type: DRUG

Other Intervention Names

Fish Oil; Nordic Naturals Pro-Omega Junior Omega-3 Fatty Acid; Nordic Omega-3 Fishies; Stimulant; Concerta; Ritalin; Focalin; Vyvanse; Adderall; Dexedrine; Amphetamine; Methylphenidate; Stratterra; Tenex

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Timothy Wilens, MD

Senior Staff, Pediatric Psychopharmaoclogy and Adult ADHD Clinic and Research Program; Associate professor of Psychiatry, Harvard Medical School; Director, Center for Addiction Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Timothy E. Wilens, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2014-P-000015

Identifier Type: -

Identifier Source: org_study_id