Omega-3 Fatty Acid Supplementation to ADHD Pharmacotherapy in ADHD Adults With DESR Traits: A Double-Blind, Placebo-Controlled, Randomized Clinical Trial
Overview
- Phase
- Phase 2
- Intervention
- ADHD Medication
- Conditions
- Attention Deficit Hyperactivity Disorder (ADHD)
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Mean Change From Baseline to Endpoint on the BRIEF-A Emotional Control Scale
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Craig B. Surman, MD
Scientific Coordinator of the Adult ADHD Program, Clinical and Research Program in Pediatric Psychopharmacology and Adult ADHD
Massachusetts General Hospital
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Omega-3 Fatty Acids
1060 mg EPA Omega-3 Fatty Acids
Intervention: ADHD Medication
Omega-3 Fatty Acids
1060 mg EPA Omega-3 Fatty Acids
Intervention: Omega-3 Fatty Acids
Placebo
Intervention: ADHD Medication
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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 the Global Assessment of Functioning (GAF) Scale(baseline to 12 weeks)
- Efficacy Measured by Mean Change From Baseline to Endpoint on BRIEF-A Subscales(baseline to 12 weeks)