Omega-3 Supplementation to ADHD Medication in Children

Phase 4

Completed

Conditions: Attention Deficit Hyperactivity Disorder
Deficient Emotional Self-Regulation

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

Registration Number: NCT02204410

Lead Sponsor: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 21

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Omega-3 Fatty Acids and Stimulant Treatment	ADHD Medication	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.
Omega-3 Fatty Acids and Stimulant Treatment	Omega-3 Fatty Acid	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.

Primary Outcome Measures

Name	Time	Method
Emotional Control Subscale of the Behavior Rating Inventory of Executive Function - Parent Form (BRIEF-Parent)	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.
Clinical Global Impression (CGI) Improvement for Deficient Emotional Self-Regulation (DESR)	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