The Food and Drug Administration on Monday for the first time gave a green light to a game-based therapeutic: a video game meant to be prescribed to kids with ADHD.
The game, known as EndeavorRx and developed by Boston-based Akili Interactive Labs, can now be marketed as a way to improve attention function in kids with ADHD as measured by computerized testing. Physicians can prescribe it to children between the ages of 8 and 12 who have an ADHD diagnosis and have demonstrated an issue with attention.
The FDA’s move is a landmark decision in the emerging digital therapeutics sector: In addition to being the first game to be marketed as a therapy for any type of condition, EndeavorRx is the first digital therapeutic meant to improve symptoms associated with ADHD, the FDA’s announcement said…The game was born in the University of California, San Francisco lab of neuroscientist Adam Gazzaley, and was licensed out by Akili, which polished and tested the game in clinical trials. Akili spent the past two years waiting on a regulatory decision from the FDA.
The use of ADHD meds without a prescription, i.e., nonmedical use, is a large and perhaps growing problem on college campuses nationwide. Although the percent of students who engage in nonmedical use of ADHD meds varies widely across different schools, rates exceeding 30% have been reported at some campuses. [Read more…] about Study: Why do (some) college students misuse ADHD medication?
Many parents, health care professionals, and educators agree that there is a pressing need to develop effective treatments for ADHD to complement or substitute for traditional medication and behavior therapy approaches. This is because such treatments do not work for everyone, important difficulties often remain even when these treatments are effective, and evidence for the long-term benefits of these treatments remains less compelling than one would like. In addition, in the case of medication treatment, some individuals experience intolerable side effects and many have concerns about taking ADHD medication for an extended period.
One alternative approach to treating ADHD has relied on the use of Compound Herbal Preparations (CHP) derived from traditional Chinese medicine. Practitioners of this approach believe that such preparations have important cognitive enhancing properties because they supply essential nutrients, fatty acids, phospholipids, amino acids, B vitamins, minerals, and other micronutrients that are important for optimal brain growth and development. As a treatment for ADHD, the idea is that many individuals with ADHD have deficiencies in essential nutrients that compromise healthy brain development and result in ADHD symptoms. Providing these nutrients via an appropriately prepared herbal compound thus has the potential to be therapeutic and reduce these symptoms.
This idea was tested recently in a randomized-controlled trial of a specific CHP for children with ADHD [Katz, Kol-Degani, & Kav-Venaki (2010). A compound herbal preparation (CHP) in the treatment of ADHD: A randomized controlled trial. Journal of Attention Disorders. Published online on March 12, 2010.] Participants were 120 6–12 year-old children newly diagnosed with ADHD based on a comprehensive diagnostic evaluation. These children were all evaluated at the Sheba Medical Center, one of the largest university-affiliated tertiary care centers in Israel.
(Editor´s note: Dr. David Rabiner, author of this article, previously reviewed a 2005 meta-analysis whose findings need to be kept in mind to contextualize this new study. In the article Dietary Intervention for ADHD: A Meta-Analysis, Dr. Rabiner concluded that “Results from this meta-analysis provide strong evidence that the behavior of children with ADHD can be made worse by dietary factors, and that eliminating AFCs from their diets will, on average, result in behavioral improvements. This result is consistent with with accumulating evidence that neurobehavioral toxicity may result from a wide variety of distributed chemicals.”)
Children were randomly assigned to receive either the CHP (n=80) or a placebo (n=40) that was specially prepared to [Read more…] about A Controlled Trial of Herbal Treatment for ADHD