Clinical trial NCT01399827: Omega-3 Fatty Acid Supplementation to ADHD Pharmacotherapy in ADHD Adults With Deficient Emotional Self-Regulation Traits
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Deficient Emotional Self-Regulation (DESR)
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2011-07-22
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Mean Change From Baseline to Endpoint on the BRIEF-A Emotional Control Scale
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Efficacy Measured by Mean Change From Baseline to Endpoint on Adult ADHD Investigator Rating Scale (AISRS) Total Score
timeFrame: baseline to 12 weeks
measure: Efficacy Measured by Mean Change From Baseline to Endpoint on Clinical Global Impression (CGI) Scale
timeFrame: baseline to 12 weeks
measure: Efficacy Measured by Mean Change From Baseline to Endpoint on BRIEF-A Subscales
timeFrame: baseline to 12 weeks
measure: Efficacy Measured by Mean Change From Baseline to Endpoint on the Global Assessment of Functioning (GAF) Scale
timeFrame: baseline to 12 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Craig Surman, MD
role: PRINCIPAL_INVESTIGATOR
References: