drugset / Trial / NCT01399827

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

NCT01399827

Phase 2 Completed 2 enrolled Massachusetts General Hospital
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2012-02
Primary completion
2017-11
Completion
2017-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator Omega-3 fatty acids Unknown 1060 mg
Comparator Amphetamine Unknown
Comparator Atomoxetine Other / unclassified
Comparator Dextroamphetamine Small molecule
Comparator Lisdexamfetamine Dimesylate Small molecule
Comparator Methylphenidate Small molecule
Comparator dexmethylphenidate Unknown
Comparator mixed amphetamine salts Unknown