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

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ClinicalTrials.gov Identifier: NCT01399827
Recruitment Status : Completed
First Posted : July 22, 2011
Results First Posted : October 23, 2018
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Craig B. Surman, MD, Massachusetts General Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder (ADHD) Deficient Emotional Self-Regulation (DESR) Drug: ADHD Medication Drug: Omega-3 Fatty Acids Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : February 2012
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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:
  • Methylphenidate extended release (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:
  • Methylphenidate extended release (OROS-MPH)
  • Concerta
  • Vyvanse
  • Dextroamphetamine
  • Adderall
  • Mixed Amphetamine Salts
  • Amphetamine
  • Strattera
  • Atomoxetine
  • Focalin
  • Dexmethylphenidate




Primary Outcome Measures :
  1. Mean Change From Baseline to Endpoint on the BRIEF-A Emotional Control Scale [ Time Frame: Baseline to 12 weeks ]
    The BRIEF-A is a 75-item questionnaire that assesses and adult's cognitive, emotional, and behavioral functions within the past month. The subject rates each question on a 3-point scale (1=Never, 2=Sometimes, 3=Often). Raw scores are calculated and used to generate T-scores for 8 scales (Inhibit, Shift, Emotional Control, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organization of Materials), 2 summary index scales (Behavioral Regulation Index and Metacognition Index), and one scale reflecting overall functioning (Global Executive Composite). T-scores range from 30 to 100, with scores ≥65 indicating clinical impairment. A reduction in score indicates improvement.


Secondary Outcome Measures :
  1. Efficacy Measured by Mean Change From Baseline to Endpoint on Adult ADHD Investigator Rating Scale (AISRS) Total Score [ Time Frame: baseline to 12 weeks ]
    The Adult ADHD Investigator Rating Scale (AISRS) measures ADHD symptoms in adults. This scale is an investigator rated scale. Higher scores on this scale indicate more severe ADHD-like symptoms. Patients symptoms are rated as "never", "rarely", "sometimes", "often", or "very often" by the investigator. Total score ranges from 0 to 54. T-scores range from 30 to 100, with scores ≥65 indicating clinical impairment. A reduction in score indicates improvement.

  2. Efficacy Measured by Mean Change From Baseline to Endpoint on Clinical Global Impression (CGI) Scale [ Time Frame: baseline to 12 weeks ]
    The Clinical Global Impression (CGI) is a 3-item observer-rated scale that measures illness severity (CGIS), global improvement or change (CGIC) and therapeutic response (CGIE). Scores range from 0 to 7 on each subscale. Total scores range from 0 to 21. T-scores range from 30 to 100, with scores ≥65 indicating clinical impairment. A reduction in score indicates improvement.

  3. Efficacy Measured by Mean Change From Baseline to Endpoint on BRIEF-A Subscales [ Time Frame: baseline to 12 weeks ]
    The BRIEF-A is a 75-item questionnaire that assesses and adult's cognitive, emotional, and behavioral functions within the past month. The subject rates each question on a 3-point scale (1=Never, 2=Sometimes, 3=Often). Raw scores are calculated and used to generate T-scores for 8 scales (Inhibit, Shift, Emotional Control, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organization of Materials), 2 summary index scales (Behavioral Regulation Index and Metacognition Index), and one scale reflecting overall functioning (Global Executive Composite). T-scores range from 30 to 100, with scores ≥65 indicating clinical impairment. A reduction in score indicates improvement.

  4. Efficacy Measured by Mean Change From Baseline to Endpoint on the Global Assessment of Functioning (GAF) Scale [ Time Frame: baseline to 12 weeks ]
    The Global Assessment of Functioning (GAF) scale is used to rate how serious a mental illness may be. Lower scores on this scale indicate a lower level of functioning and higher severity of symptoms. Total scores range from 0 to 100.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01399827


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Craig Surman, MD Massachusetts General Hospital
  Study Documents (Full-Text)

Documents provided by Craig B. Surman, MD, Massachusetts General Hospital:

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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
First Posted: July 22, 2011    Key Record Dates
Results First Posted: October 23, 2018
Last Update Posted: October 23, 2018
Last Verified: September 2018

Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Methylphenidate
Amphetamine
Dextroamphetamine
Dexmethylphenidate Hydrochloride
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic Agents
Adrenergic Uptake Inhibitors