Omega-3 Fatty Acid Supplementation to ADHD Pharmacotherapy in ADHD Adults With Deficient Emotional Self-Regulation Traits

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 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: July 23, 2014
Last verified: July 2014
  Purpose

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 RBC cell membranes. This study will be a 12-week trial with adults 18-55 years of age with ADHD and symptoms of DESR.


Condition Intervention Phase
Attention Deficit Hyperactivity Disorder (ADHD)
Deficient Emotional Self-Regulation (DESR)
Drug: ADHD Medication
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 Supplementation to ADHD Pharmacotherapy in ADHD Adults With DESR Traits: A Double-Blind, Placebo-Controlled, Randomized Clinical Trial

Resource links provided by NLM:


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 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Omega-3 Fatty Acids
1060 mg EPA Omega-3 Fatty Acids
Drug: ADHD Medication
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.
Other Names:
  • OROS-MPH
  • Concerta
  • Vyvanse
  • Dextroamphetamine
  • Adderall
  • Mixed Amphetamine Salts
  • Amphetamine
  • Strattera
  • Atomoxetine
  • Focalin
  • Dexmethylphenidate
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: ADHD Medication
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.
Other Names:
  • OROS-MPH
  • Concerta
  • Vyvanse
  • Dextroamphetamine
  • Adderall
  • Mixed Amphetamine Salts
  • Amphetamine
  • Strattera
  • Atomoxetine
  • Focalin
  • Dexmethylphenidate

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Lauren Rhodewalt, BS 617-643-1432 lrhodewalt@mgh.harvard.edu
Contact: Leah Feinberg, BS 617-726-4651 lkfeinberg@mgh.harvard.edu

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: July 23, 2014
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
Dyskinesias
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Amphetamine
Dexmethylphenidate
Adrenergic Agents
Adrenergic Uptake Inhibitors
Autonomic Agents
Central Nervous System Agents
Central Nervous System Stimulants
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sympathomimetics
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014