The study is a comparator-controlled, randomised, double-blinded intervention study aimed at assessing the effects of the investigational device MEL-T01, Meliora, on the symptoms of major depressive disorder (MDD). MEL-S01 acts as a comparator. MEL-T01 is a game-based digital-therapeutics (DTx) medical software device developed at Aalto University and is intended to be used as a treatment for MDD together with treatment-as-usual (TAU). MEL-T01 implements personalised cognitive training to alleviate MDD symptoms and improve cognitive performance in MDD subjects.~Subjects volunteering to participate in this investigation are adults whose MDD is confirmed through MINI interview. They have an on-going mental health treatment contact with a mental health professional. The subjects are randomised into three arms with equal probabilities in blocks of six consecutive subjects. Subjects in the MEL-T01 and MEL-S01 arms are engaged in the intervention for 12 weeks while those in the TAU arm are on a follow-up period during these 12 weeks. After this 12-week period, the subjects in MEL-T01 and MEL-S01 arms enter a 12-week follow-up period and the subjects in TAU arm engage with either the MEL-T01 or MEL-S01 intervention (randomised at T0 with equal probability) for 12 weeks.~The subjects are recommended to play the investigational-device game for a total of 48 hours during the 12 weeks of active intervention with a recommended weekly dose of 4 hours. A minimum of 24 hours is needed for inclusion to hypothesis testing. The subjects are limited to a daily maximum of 1.5 hours of game time.~The subjects' mental health symptoms and well-being are evaluated through online questionnaires five times: before subjects are randomised into one of the three groups (T0), and then 4 (T1), 8 (T2), 12 (T3), and 24 (T4) weeks after the study has begun.
The purpose of the study is to evaluate the effects of a game-based digital-therapeutics (DTx) medical software device on the symptoms of depression in adults with confirmed major depressive disorder.