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

This study is currently recruiting participants.
Verified May 2013 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Craig B. Surman, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01399827
First received: July 20, 2011
Last updated: May 10, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Attention Deficit Hyperactivity Disorder (ADHD)
Deficient Emotional Self-Regulation (DESR)
 Drug: OROS-Methylphenidate
Drug: Omega-3 Fatty Acids
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Omega-3 Fatty Acid Supplement to OROS-Methylphenidate Pharmacotherapy in ADHD Adults With DESR Traits: A Double-Blind, Placebo-Controlled, Randomized Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Efficacy assessed by mean change from baseline to endpoint on the BRIEF-A Emotional Control scale [ Time Frame: baseline to 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: February 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Omega-3 Fatty Acids 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
Placebo Comparator: Placebo Drug: OROS-Methylphenidate
OROS-Methylphenidate prescribed to all participants.
Other Names:
  • OROS-MPH
  • Concerta

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01399827

Contacts
Contact: Rebecca Grossman, BA 617-643-1432 rgrossman1@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Craig Surman, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Craig B. Surman, MD, Scientific Coordinator of the Adult ADHD Program, Clinical and Research Program in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01399827     History of Changes
Other Study ID Numbers: 2010-P-002435
Study First Received: July 20, 2011
Last Updated: May 10, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Methylphenidate
 Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013