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Omega-3 Supplementation to ADHD Medication in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02204410
Recruitment Status : Completed
First Posted : July 30, 2014
Results First Posted : June 29, 2017
Last Update Posted : June 29, 2017
Information provided by (Responsible Party):
Timothy Wilens, MD, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Deficient Emotional Self-Regulation Dietary Supplement: Omega-3 Fatty Acid Drug: ADHD Medication Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Omega-3 Fatty Acid Supplementation to ADHD Medication in Children With ADHD and Deficits in Emotional Self-Regulation
Study Start Date : July 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : August 2016

Arm Intervention/treatment
Experimental: 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.
Dietary Supplement: Omega-3 Fatty Acid
Other Names:
  • Fish Oil
  • Nordic Naturals Pro-Omega Junior Omega-3 Fatty Acid
  • Nordic Omega-3 Fishies

Drug: ADHD Medication
Other Names:
  • Stimulant
  • Concerta
  • Ritalin
  • Focalin
  • Vyvanse
  • Adderall
  • Dexedrine
  • Amphetamine
  • Methylphenidate
  • Stratterra
  • Tenex

Primary Outcome Measures :
  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:

    1. Very much improved
    2. Much improved
    3. Minimally improved
    4. No change
    5. Minimally worse
    6. Much worse
    7. Very much worse

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02204410

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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
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Principal Investigator: Timothy E. Wilens, MD Massachusetts General Hospital

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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, Massachusetts General Hospital Identifier: NCT02204410     History of Changes
Other Study ID Numbers: 2014-P-000015
First Posted: July 30, 2014    Key Record Dates
Results First Posted: June 29, 2017
Last Update Posted: June 29, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Timothy Wilens, MD, Massachusetts General Hospital:
Attention Deficit Hyperactivity Disorder
Deficient Emotional Self-Regulation
Emotional Dysregulation
Omega-3 Fatty Acids
Fish Oil
Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents