The U.S. Food and Drug Administration (FDA) has green-lighted the first prescription therapy app as an add-on treatment to reduce symptoms of major depressive disorder in people age 22 and older who are already taking an antidepressant.
“Only a third of patients who are diagnosed with depression and receive antidepressants as their first-line treatment are successful,” said David Benshoof Klein, a cofounder and the chief executive officer at Click Therapeutics, in the statement. “These patients need new options that capitalize on proven-effective treatment strategies. [This app] provides hope for those who are looking for new treatment options, especially one that is easily accessible through the device in the palm of your hand.”
The FDA granted clearance for the app on the basis of results from a 13-week controlled trial involving about 400 adults between ages 22 and 64 diagnosed with major depressive disorder who were already taking an antidepressant. In the trial, participants were randomized to receive either Rejoyn or a sham control app.
People treated with Rejoyn showed an improvement in depression symptoms. Symptom improvement was measured with several standard patient questionnaires.
One month after completing the six-week treatment program, participants using the app continued to show improvement. No side effects were reported.
The program consists of three brief therapeutic lessons per week, taking about five minutes each, and three clinically validated cognitive emotional training exercises per week, taking about 20 to 30 minutes each, for a total time commitment of under two hours per week. Each new course of treatment requires a new prescription.
How a Smartphone App Can Make a Difference for Depression
Clinical research has shown that chemical imbalances are not the only cause of depression, though many common treatments target these neurochemical abnormalities.
Some people with depression show hyperactivity of the neural systems involved in emotion processing, such as the amygdala, coupled with decreased activity of systems involved in cognitive control and emotion regulation, such as the prefrontal cortex.
The Rejoyn app relies on a technology called Emotional Faces Memory Task (EFMT), which asks users to identify an emotion when looking at a series of faces. For each face, they are asked to identify the number of faces earlier in the series in which they encountered the same emotion. This aims to balance brain activity in regions to work in concert with each other.
This Depression App Is Promising, but Questions Remain
For John Torous, MD, the director of the division of digital psychiatry at Beth Israel Deaconess Medical Center in Boston, the new app represents an “exciting” new option for depression therapy.
“We have effective depression treatments already, but not everyone responds,” says Dr. Torous, who was not involved in the development of Rejoyn. “So having another tool that people can try is useful.”
He emphasizes that the app is not a stand-alone treatment. It’s approved to be used in conjunction with ongoing care and under the guidance of a physician.
While this app requires a prescription and is classified as a low- to medium-risk “medical device,” many other wellness apps intended to help with mental health are also available to consumers.
Torous and his colleagues run the website MINDapps.org, which indexes hundreds of mental health apps, including those for depression. These apps are not FDA-approved, they do not require a prescription, and many are free.
Some apps have very impressive evidence supporting their effectiveness, while others do not, according to Torous, who also serves on an American Psychiatric Association panel that evaluates apps. “You can use our website to see how many apps exist today for depression,” he says.
John Kraus, MD, PhD, the executive vice president and chief medical officer at Otsuka, stresses that while Rejoyn is delivered through an interactive smartphone app, it is considered a medical device and treatment, not a wellness app.
“This is a prescription therapeutic intended to treat or alleviate a disease, disorder, condition, or injury, by generating and delivering a medical intervention that has a demonstrable positive therapeutic impact on a patient’s health, which is only available to patients by prescription from a healthcare provider,” says Dr. Kraus.
He adds that for Rejoyn to be cleared as a medical device by the FDA, it was rigorously assessed using the same clinical scales used in drug trials. How results from the app translate into the real world still isn’t known. As Torous notes, it’s not certain if everyday users will stick with the program and remain engaged, and if clinicians will feel comfortable prescribing the app and integrating it into treatment.
The company has not yet posted a price for the tool, but indicated it will be accessible and affordable. It is also unclear at this time if insurance will help cover the cost.
The product is expected to be available for download from iOS and Android app stores this summer. Prescriptions for the program need to be filled by a pharmacist, who then sends an access code to the patient.
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