Back to resultsOmega-3 Supplementation to ADHD Medication in Children
Primary Purpose
Attention Deficit Hyperactivity Disorder, Deficient Emotional Self-Regulation
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Omega-3 Fatty Acid
ADHD Medication
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring ADHD, Attention Deficit Hyperactivity Disorder, DESR, Deficient Emotional Self-Regulation, Emotional Dysregulation, Omega-3 Fatty Acids, Fish Oil
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
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Omega-3 Fatty Acids and Stimulant Treatment
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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:
Very much improved
Much improved
Minimally improved
No change
Minimally worse
Much worse
Very much worse
Secondary Outcome Measures
Full Information
NCT ID
NCT02204410
First Posted
July 28, 2014
Last Updated
May 30, 2017
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02204410
Brief Title
Omega-3 Supplementation to ADHD Medication in Children
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 Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Omega-3 Fatty Acids and Stimulant Treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3 Fatty Acid
Other Intervention Name(s)
Fish Oil, Nordic Naturals Pro-Omega Junior Omega-3 Fatty Acid, Nordic Omega-3 Fishies
Intervention Type
Drug
Intervention Name(s)
ADHD Medication
Other Intervention Name(s)
Stimulant, Concerta, Ritalin, Focalin, Vyvanse, Adderall, Dexedrine, Amphetamine, Methylphenidate, Stratterra, Tenex
Primary Outcome Measure Information:
Title
Emotional Control Subscale of the Behavior Rating Inventory of Executive Function - Parent Form (BRIEF-Parent)
Description
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.
Time Frame
Baseline and 12 Weeks
Title
Clinical Global Impression (CGI) Improvement for Deficient Emotional Self-Regulation (DESR)
Description
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
Time Frame
Baseline and 12 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy E. Wilens, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Omega-3 Supplementation to ADHD Medication in Children
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