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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

July 20, 2011
July 23, 2014
February 2012
September 2015   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01399827 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Omega-3 Fatty Acid Supplementation to ADHD Pharmacotherapy in ADHD Adults With Deficient Emotional Self-Regulation Traits
Omega-3 Fatty Acid Supplementation to ADHD Pharmacotherapy in ADHD Adults With DESR Traits: A Double-Blind, Placebo-Controlled, Randomized Clinical Trial

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Attention Deficit Hyperactivity Disorder (ADHD)
  • Deficient Emotional Self-Regulation (DESR)
  • 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
  • Active Comparator: Omega-3 Fatty Acids
    1060 mg EPA Omega-3 Fatty Acids
    Interventions:
    • Drug: ADHD Medication
    • Drug: Omega-3 Fatty Acids
  • Placebo Comparator: Placebo
    Intervention: Drug: ADHD Medication
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
November 2015
September 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years
No
Contact: Lauren Rhodewalt, BS 617-643-1432 lrhodewalt@mgh.harvard.edu
Contact: Leah Feinberg, BS 617-726-4651 lkfeinberg@mgh.harvard.edu
United States
 
NCT01399827
2010-P-002435
No
Craig B. Surman, MD, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Craig Surman, MD Massachusetts General Hospital
Massachusetts General Hospital
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP