Status:
COMPLETED
Omega-3 Fatty Acid Supplementation to ADHD Pharmacotherapy in ADHD Adults With Deficient Emotional Self-Regulation Traits
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Attention Deficit Hyperactivity Disorder (ADHD)
Deficient Emotional Self-Regulation (DESR)
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
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 Dis...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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.
- Exclusion Criteria
- 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.
Exclusion
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2017
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01399827
Start Date
February 1 2012
End Date
November 1 2017
Last Update
October 23 2018
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114