Omega-3 Supplementation to ADHD Medication in Children
Condition: Attention Deficit Hyperactivity Disorder; Deficient Emotional Self-Regulation
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: Omega-3 Fatty Acid; ADHD Medication
Intervention MeSH terms: Methylphenidate; Amphetamine; Adderall; Dextroamphetamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: ADHD; Attention Deficit Hyperactivity Disorder; DESR; Deficient Emotional Self-Regulation; Emotional Dysregulation; Omega-3 Fatty Acids; Fish Oil

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