Omega-3 Supplementation to ADHD Medication in Children

NCT02204410 | Completed Phase 4 Results

• 1 other identifier: 2014-P-000015
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Keywords

ADHD; Attention Deficit Hyperactivity Disorder; DESR; Deficient Emotional Self-Regulation; Emotional Dysregulation; Omega-3 Fatty Acids; Fish Oil

Outcome Measures

Primary Outcomes (2)

• Emotional Control Subscale of the Behavior Rating Inventory of Executive Function - Parent Form (BRIEF-Parent)

  The Behavior Rating Inventory of Executive Function - Parent Form (BRIEF-Parent) 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. The Emotional Control subscale measures the impact of executive function problems on emotional expression and assesses a child's ability to modulate or control his or her emotional responses. It is a 10-item subscale, and each item is scored "Never," "Sometimes," or "Often." Raw scores for all scales are computed with Software Portfolio (BRIEF-SP), which provides a raw score and T score (based on child's age) for each scale. Higher scores represent more greater emotional dysregulation.

  Baseline and 12 Weeks

• Clinical Global Impression (CGI) Improvement for Deficient Emotional Self-Regulation (DESR)

  The Clinical Global Impression (CGI) is a clinician rated measure of illness severity, improvement, and efficacy of treatment (collected at all study visits). We examined the CGI Improvement specifically. The CGI Improvement for Deficient Emotional Self-Regulation (DESR) was reported at baseline and completion. The CGI-I is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. It is rated as: 1. Very much improved 2. Much improved 3. Minimally improved 4. No change 5. Minimally worse 6. Much worse 7. Very much worse

  Baseline and 12 Weeks

Study Arms (1)

Omega-3 Fatty Acids and Stimulant Treatment

EXPERIMENTAL

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.

Dietary Supplement: Omega-3 Fatty Acid; Drug: ADHD Medication

Interventions

Omega-3 Fatty Acid DIETARY_SUPPLEMENT

Also known as: Fish Oil, Nordic Naturals Pro-Omega Junior Omega-3 Fatty Acid, Nordic Omega-3 Fishies

Omega-3 Fatty Acids and Stimulant Treatment

ADHD Medication DRUG

Also known as: Stimulant, Concerta, Ritalin, Focalin, Vyvanse, Adderall, Dexedrine, Amphetamine, Methylphenidate, Stratterra, Tenex

Omega-3 Fatty Acids and Stimulant Treatment

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Fatty Acids, Omega-3; Fish Oils; Central Nervous System Stimulants; Methylphenidate; Dexmethylphenidate Hydrochloride; Lisdexamfetamine Dimesylate; Adderall; Dextroamphetamine; Amphetamine; Guanfacine

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Oils; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Amphetamines; Phenethylamines; Ethylamines; Amines; Guanidines; Amidines

Results Point of Contact

• Title: Dr. Timothy Wilens
• Organization: Massachusetts General Hospital

twilens@mgh.harvard.edu

(617)643-3481

Study Officials

• Timothy E. Wilens, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Staff, Pediatric Psychopharmaoclogy and Adult ADHD Clinic and Research Program; Associate professor of Psychiatry, Harvard Medical School; Director, Center for Addiction Medicine

Study Record Dates

• First Submitted: July 28, 2014
• First Posted: July 30, 2014
• Study Start: July 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: August 1, 2016
• Last Updated: June 29, 2017
• Results First Posted: June 29, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)