FDA clears first digital treatment for depression, but experts caution that research is still early [Video]

The US Food and Drug Administration is allowing the use of Rejoyn, the first prescription digital treatment for major depressive disorder.

Rejoyn, made by Otsuka Pharmaceutical and Click Therapeutics, is a smartphone app intended for use alongside antidepressant medications for people 22 and older who have a diagnosis of major depressive disorder. It employs a six-week program that combines a new approach called cognitive-emotional training and cognitive behavioral therapy lessons, according to a news release.

Since Rejoyn is classified as a low- to medium-risk medical device, it needed only to prove that it is “substantially equivalent” to another marketed device – meaning it is just as safe and effective – to gain FDA clearance.

“Rejoyn represents a novel and exciting adjunctive treatment option to address major depressive disorder symptoms that complements the current standard of care,” Dr. John Kraus, executive vice president and chief medical officer at Otsuka, said in …