Clinical trial NCT02204410: 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
Overall status: COMPLETED
Phase: PHASE4
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
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2014-07-30
Enrollment: 21
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Emotional Control Subscale of the Behavior Rating Inventory of Executive Function - Parent Form (BRIEF-Parent)
timeFrame: Baseline and 12 Weeks
measure: Clinical Global Impression (CGI) Improvement for Deficient Emotional Self-Regulation (DESR)
timeFrame: Baseline and 12 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Timothy E. Wilens, MD
role: PRINCIPAL_INVESTIGATOR
References: