App to support people with depression launches in GB

A smartphone app developed by Otsuka and digital health firm Click Therapeutics has been launched in Great Britain – its first European market – as a prescription digital therapeutic (DTx) for people living with depression.

Called Rejoyn (formerly CT-152), it is the first prescription-only app for depressive disorder episodes to be made available in GB and is currently available within select NHS trusts after being trialled last year. It is UKCA-marked as software-as-a-medical-device (SaMD) and is available through the App Store and Google Play, but requires a referral from a doctor or therapist.

The DTx is designed to be used alongside the existing care plan for people with depression to manage their emotions more effectively using cognitive behavioural therapy (CBT) techniques and – according to its developers – has been shown to reduce the symptoms of depressive disorder when given as a six-week treatment programme.

It provides brain exercises and therapeutic lessons designed to tap into the brain's natural ability to change, known as neuroplasticity, and helps users stick to the course with text messages and in-app notifications.

Exercises take 20 to 30 minutes and are completed three times a week, while five-minute lessons – covering ways to handle strong emotions, reframe negative thinking, and take positive actions – are also done three times weekly.

The premise is that in some people with depression, the area of the brain that deals with emotion (the amygdala) does not communicate properly with the area that governs thinking (the prefrontal cortex), leading to difficulties in processing feelings. Rejoyn's brain training exercises are designed to activate both parts of the brain at the same time and improve communication between them.

In the pivotal Mirai study, which involved 286 people with major depressive disorder (MDD), patients using the app achieved an average 8.78-point reduction change from baseline to week six in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score – versus 6.66 points for a sham group – meeting the primary endpoint for efficacy.

The full or partial response rate to the app was 48.3%, compared to 37.5% for the control group at that timepoint, with patients continuing to have reduced symptoms at week 10.

In a statement, Otsuka's UK subsidiary said additional NHS trusts are expected to arrange for provision of the treatment within the next 12 months.

Rejoyn is the first DTx to emerge from a collaboration set up in 2019 between Click and Otsuka, worth $300 million, focusing on the development of DTx software. It has also been approved in the US, launching there last year.