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

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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.

Depression is one of the most common mental health disorders in the US. About 18% of American adults - more than 1 in 6 - say they are depressed or receiving treatment for depression, a 2023 Gallup report found. Research has also found that up to 30% of people who take antidepressant medications are partial responders, meaning they continue to have depressive symptoms while using the drugs.

Dr. John Torous, director of the Division of Digital Psychiatry at Beth Israel Deaconess Medical Center, who was not involved in the development of Rejoyn, said that this cognitive-emotional training approach is not a well-established mechanism and that the research is still exploratory. Torous said that while it is important to note that the trial did not prove that Rejoyn has a statistically significant benefit, the app is also not designed to be a standalone treatment.

Rejoyn will require a prescription for download and will become available in late 2024, according to the news release. Otsuka said it will make try to make the tool "accessible and affordable" but did not specify the price.

Source: Healthcare Press (healthcarepress.net)

 

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