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

NCT01399827 | Completed Phase 2 Results

• 1 other identifier: 2010-P-002435
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Hyperactivity Disorder (ADHD); Deficient Emotional Self-Regulation (DESR)

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline to Endpoint on the BRIEF-A Emotional Control Scale

  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.

  Baseline to 12 weeks

Secondary Outcomes (4)

• Efficacy Measured by Mean Change From Baseline to Endpoint on Adult ADHD Investigator Rating Scale (AISRS) Total Score

  baseline to 12 weeks

• Efficacy Measured by Mean Change From Baseline to Endpoint on Clinical Global Impression (CGI) Scale

  baseline to 12 weeks

• Efficacy Measured by Mean Change From Baseline to Endpoint on BRIEF-A Subscales

  baseline to 12 weeks

• Efficacy Measured by Mean Change From Baseline to Endpoint on the Global Assessment of Functioning (GAF) Scale

  baseline to 12 weeks

Study Arms (2)

Omega-3 Fatty Acids

ACTIVE COMPARATOR

1060 mg EPA Omega-3 Fatty Acids

Drug: ADHD Medication; Drug: Omega-3 Fatty Acids

Placebo

PLACEBO COMPARATOR

Drug: ADHD Medication

Interventions

ADHD Medication DRUG

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.

Also known as: Methylphenidate extended release (OROS-MPH), Concerta, Vyvanse, Dextroamphetamine, Adderall, Mixed Amphetamine Salts, Amphetamine, Strattera, Atomoxetine, Focalin, Dexmethylphenidate

Omega-3 Fatty Acids; Placebo

Omega-3 Fatty Acids DRUG

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.

Also known as: Nordic Natural EPA Xtra

Omega-3 Fatty Acids

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female adults ages 18-55 years.
• 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.
• 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.
• 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.

You may not qualify if:

• 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.
• 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, endocrinologic (thyroid), neurologic (seizure), immunologic, or hematologic disease.
• Glaucoma.
• 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.
• 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 shellfish; multiple adverse drug reactions.
• Any other concomitant medication with primarily central nervous system activity other than specified in Concomitant Medication portion of the protocol.
• Current use of Monoamine Oxidase (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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate; Lisdexamfetamine Dimesylate; Dextroamphetamine; Adderall; Amphetamine; Atomoxetine Hydrochloride; Dexmethylphenidate Hydrochloride; Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Amphetamines; Phenethylamines; Ethylamines; Amines; Propylamines; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Results Point of Contact

• Title: Craig Surman, MD
• Organization: Massachusetts General Hospital

csurman@partners.org

617-726-8392

Study Officials

• Craig Surman, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientific Coordinator of the Adult ADHD Program, Clinical and Research Program in Pediatric Psychopharmacology and Adult ADHD

Study Record Dates

• First Submitted: July 20, 2011
• First Posted: July 22, 2011
• Study Start: February 1, 2012
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: October 23, 2018
• Results First Posted: October 23, 2018

Record last verified: 2018-09

Locations

US (1)