Omega-3 Supplementation to ADHD Medication in Children
This trial has been completed.
|Conditions||attention deficit hyperactivity disorder, deficient emotional self-regulation|
|Treatments||omega-3 fatty acid, adhd medication|
|Sponsor||Massachusetts General Hospital|
|Start date||July 2014|
|End date||May 2016|
|Trial size||21 participants|
|Trial identifier||NCT02204410, 2014-P-000015|
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 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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Behavior Rating Inventory of Executive Function- Parent Form Emotional Control Subscale
time frame: 12 Weeks
Male or female participants from 6 years up to 17 years old.
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
|Official title||A Pilot Study of Omega-3 Fatty Acid Supplementation to ADHD Medication in Children With ADHD and Deficits in Emotional Self-Regulation|
|Principal investigator||Timothy E. Wilens, MD|
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