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

Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Attention Deficit Hyperactivity Disorder (ADHD); Deficient Emotional Self-Regulation (DESR)

Intervention: ADHD Medication (Drug); Omega-3 Fatty Acids (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Massachusetts General Hospital

Official(s) and/or principal investigator(s):
Craig Surman, MD, Principal Investigator, Affiliation: Massachusetts General Hospital

Overall contact:
Lauren Rhodewalt, BS, Phone: 617-643-1432, Email: lrhodewalt@mgh.harvard.edu

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

Clinical Details

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 design: Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Efficacy assessed by mean change from baseline to endpoint on the BRIEF-A Emotional Control scale

Secondary outcome:

Efficacy measured by mean change from baseline to endpoint on AISRS total score

Efficacy measured by mean change from baseline to endpoint on CGI

Efficacy measured by mean change from baseline to endpoint on BRIEF-A subscales

Efficacy measured by mean change from baseline to endpoint on GAF

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

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.

Locations and Contacts

Lauren Rhodewalt, BS, Phone: 617-643-1432, Email: lrhodewalt@mgh.harvard.edu

Massachusetts General Hospital, Boston, Massachusetts 02114, United States; Recruiting
Additional Information

Starting date: February 2012
Last updated: February 27, 2015

Page last updated: August 23, 2015

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