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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

Tracking Information
First Submitted Date  ICMJE July 20, 2011
First Posted Date  ICMJE July 22, 2011
Results First Submitted Date  ICMJE May 17, 2018
Results First Posted Date  ICMJE October 23, 2018
Last Update Posted Date October 23, 2018
Study Start Date  ICMJE February 2012
Actual Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 21, 2011)
Efficacy assessed by mean change from baseline to endpoint on the BRIEF-A Emotional Control scale [ Time Frame: Baseline to 12 weeks ]
Change History Complete list of historical versions of study NCT01399827 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2011)
  • Efficacy measured by mean change from baseline to endpoint on AISRS total score [ Time Frame: baseline to 12 weeks ]
  • Efficacy measured by mean change from baseline to endpoint on CGI [ Time Frame: baseline to 12 weeks ]
  • Efficacy Measured by Mean Change From Baseline to Endpoint on BRIEF-A Subscales [ Time Frame: baseline to 12 weeks ]
  • Efficacy measured by mean change from baseline to endpoint on GAF [ Time Frame: baseline to 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Omega-3 Fatty Acid Supplementation to ADHD Pharmacotherapy in ADHD Adults With Deficient Emotional Self-Regulation Traits
Official Title  ICMJE Omega-3 Fatty Acid Supplementation to ADHD Pharmacotherapy in ADHD Adults With DESR Traits: A Double-Blind, Placebo-Controlled, Randomized Clinical Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Attention Deficit Hyperactivity Disorder (ADHD)
  • Deficient Emotional Self-Regulation (DESR)
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 28, 2018)
2
Original Estimated Enrollment  ICMJE
 (submitted: July 21, 2011)
30
Actual Study Completion Date  ICMJE November 2017
Actual Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01399827
Other Study ID Numbers  ICMJE 2010-P-002435
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Craig B. Surman, MD, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Craig Surman, MD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date September 2018

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