Omega-3 Fatty Acid Supplementation to ADHD Pharmacotherapy in ADHD Adults With Deficient Emotional Self-Regulation Traits
Condition: Attention Deficit Hyperactivity Disorder (ADHD); Deficient Emotional Self-Regulation (DESR)
MeSH terms: Attention Deficit Disorder with Hyperactivity
Intervention: ADHD Medication; Omega-3 Fatty Acids
Intervention description: For those subjects not on stable ADHD treatment (defined as a stable, effective dose for at least one month, determined by the study clinician, of a medication that is FDA approved to treat ADHD), OROS-Methylphenidate will be openly prescribed. Subjects on a stable dose of medication for ADHD will be instructed to continue on their current dose of medication.; Omega-3 Fatty Acids prescribed to participants randomized to active medication. They may be randomized to receive 1060mg of EPA (2 capsules containing 530mg EPA and 137mg DHA). Dosage will remain constant throughout study.
Intervention MeSH terms: Methylphenidate; Amphetamine; Adderall; Dexmethylphenidate Hydrochloride; Dextroamphetamine; Atomoxetine Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to a) assess the efficacy of omega-3 fatty acids in the
      treatment of Deficient Emotional Self-Regulation (DESR) among stimulant treated Attention
      Deficit Hyperactivity Disorder (ADHD) adults, b) assess the side effect profile of omega-3
      fatty acids in the treatment of DESR among stimulant treated ADHD adults, c) assess effects
      of omega-3 fatty acid supplementation on ADHD symptoms and associated features in stimulant
      treated ADHD adults, and d) predict value of fatty acids present in red blood cell membranes.
      This study will be a 12-week trial with adults 18-55 years of age with ADHD and symptoms of
      DESR.
    

Eligibility criteria:

        Inclusion Criteria

          1. Male or female adults ages 18-55 years.

          2. A diagnosis of childhood onset Attention Deficit Hyperactivity Disorder, according to
             the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
             based on clinical assessment. Childhood onset will be defined according to established
             research criteria, requiring onset of two symptoms of inattentive or of
             impulsive/hyperactive traits by the age of 12.

          3. A score of 24 or more on the Adult ADHD Investigator Symptom Report Scale (AISRS), or,
             for those individuals stably treated with a medication approved by the Food and Drug
             Administration for ADHD, a Clinical Global Impression (CGI) ADHD severity score of no
             greater than 4 ("moderately ill").

             Those subjects treated with traditional ADHD pharmacotherapy must be on a stable,
             effective dose (per clinician evaluation) of an FDA-approved treatment for ADHD for at
             least one month at the time of enrollment.

          4. A Deficient Emotional Self Regulation (DESR) T-score on the Behavior Rating Inventory
             of Executive Function-Adult Version (BRIEF-A) Emotional Control Scale of at least 65
             and/or a score of 99 or more on the DESR.

        Exclusion Criteria

          1. For those subjects not treated for their ADHD at the time of enrollment, a history of
             non-response or intolerance to methylphenidate at adequate doses as determined by the
             clinician.

          2. A history of intolerance to omega-3 fatty acids as determined by the clinician.

          3. Pregnant or nursing females.

          4. Serious, unstable medical illness including hepatic, renal, gastroenterological,
             respiratory, cardiovascular, endocrinologic (thyroid), neurologic (seizure),
             immunologic, or hematologic disease.

          5. Glaucoma.

          6. Clinically unstable psychiatric conditions including suicidality, homicidality,
             bipolar disorder, psychosis, or lifetime history of a clinically serious condition
             potentially exacerbated by a stimulant such as mania, or psychosis.

          7. Tics or a family history or diagnosis of Tourette's syndrome.

          8. Current (within 3 months) DSM-IV criteria for abuse or dependence with any
             psychoactive substance other than nicotine.

          9. Allergies to fish or shellfish; multiple adverse drug reactions.

         10. Any other concomitant medication with primarily central nervous system activity other
             than specified in Concomitant Medication portion of the protocol.

         11. Current use of Monoamine Oxidase (MAO) Inhibitor or use within the past two weeks.

         12. Investigator and his/her immediate family; defined as the investigator's spouse,
             parent, child, grandparent, or grandchild.