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Completed

NCT Number: NCT02204410

Omega-3 Supplementation to ADHD Medication in Children

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.

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Key information

Conditions

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Deficient Emotional Self-Regulation Mental Disorders Neurodevelopmental Disorders

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omega-3 fatty acid

Dietary Supplement

Other names: Fish Oil, Nordic Naturals Pro-Omega Junior Omega-3 Fatty Acid, Nordic Omega-3 Fishies

ADHD medication

Drug

Other names: Stimulant, Concerta, Ritalin, Focalin, Vyvanse, Adderall, Dexedrine, Amphetamine, Methylphenidate, Stratterra, Tenex

Primary outcomes

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

    Time frame: Baseline and 12 Weeks

    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.

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

    Time frame: Baseline and 12 Weeks

    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:

    • Very much improved
    • Much improved
    • Minimally improved
    • No change
    • Minimally worse
    • Much worse
    • Very much worse

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 30, 2014
Registry last updated
Jun 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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