Omega-3 Fatty Acid Supplement to OROS-Methylphenidate Pharmacotherapy in Attention Deficit Hyperactivity Disorder (ADHD) Adults With Deficient Emotional Self-Regulation (DESR) Traits

• Efficacy measured by mean change from baseline to endpoint on AISRS total score [ Time Frame: baseline to 12 weeks ] [ Designated as safety issue: No ]
• Efficacy measured by mean change from baseline to endpoint on CGI [ Time Frame: baseline to 12 weeks ] [ Designated as safety issue: No ]
• Efficacy measured by mean change from baseline to endpoint on BRIEF-A subscales [ Time Frame: baseline to 12 weeks ] [ Designated as safety issue: No ]
• Efficacy measured by mean change from baseline to endpoint on GAF [ Time Frame: baseline to 12 weeks ] [ Designated as safety issue: No ]

The purpose of this study is to a) assess the efficacy od 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 effecrs 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 RBC cell membranes. This study will be a 12-week trial with adults 18-50 years of age with ADHD and symptoms of DESR.

• Attention Deficit Hyperactivity Disorder (ADHD)
• Deficient Emotional Self-Regulation (DESR)

• Drug: OROS-Methylphenidate
  OROS-Methylphenidate prescribed to all participants.
  Other Names:

  • OROS-MPH
  • Concerta
• Drug: Omega-3 Fatty Acids
  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.
  Other Name: Nordic Natural EPA Xtra

• Active Comparator: Omega-3 Fatty Acids
  Interventions:

  • Drug: OROS-Methylphenidate
  • Drug: Omega-3 Fatty Acids
• Placebo Comparator: Placebo
  Intervention: Drug: OROS-Methylphenidate

Inclusion Criteria:

• Male or female adults ages 18-55.
• A diagnosis of childhood onset ADHD, according to the DSM-IV, based on clinical assessment.
• A score of 24 or more on the Adult ADHD Investigator Symptom Report Scale (AISRS)
• A DESR T-score on the BRIEF-A Emotional Control Scale of at least 65.
• A score of 99 or greater on the Deficient Emotional Regulation Scale (DERS)

Exclusion Criteria:

• A history of non-response or intolerance to methylphendiate at adequate doses as determined by the clinician.
• A history of intolerance to omega-3 fatty acids as determined by the clinician.
• Pregnant or nursing females.
• Serious, unstable medical illness including hepatic, renal, gastroenterological, respiratory, cardiovascular, endrocrinologic (thyroid), neurologic (seizure), immunologic, or hematologic disease.
• Glaucoma.
• Clinically unstable psychiatric conditions including suicidality, homicidality, bipolar disorder, psychosis, or a lifetime history of a clinically serious condition potentially exacerbated by a stimulant, such as mania or psychosis.
• Tics or a family history or diagnosis of Tourette's syndrome.
• Current (within 3 months) DSM-IV criteria for abuse or dependence with any psychoactive substance other than nicotine.
• Allergies to fish or shellfood; multiple adverse drug reactions.
• Any other concomitant medication with primarily central nervous system activity other than judged to be acceptable by clinician. Stable antidepressants may be acceptable.
• Current use of MAO Inhibitor or use within the past two weeks.
• Investigator and his/her immediate family, defined as the investigator's spouse, parent, child, grandparent, or grandchild.