Evaluating the Efficacy of a Digital Therapeutic (CT-152) as an Adjunct to Antidepressant Treatment in Adults With Major Depressive Disorder: Protocol for the MIRAI Remote Study
ABSTRACT
Major depressive disorder (MDD) is a common and highly disabling condition. Many individuals with MDD do not experience full symptom relief with current treatments, so new options are needed. This study describes a phase 3 trial evaluating the efficacy of a smartphone app-based digital therapeutic (CT-152) as an additional treatment for adults with MDD who have not responded adequately to antidepressant therapy.
OBJECTIVE
The study aimed to assess the effectiveness of CT-152 as an adjunct to antidepressant therapy in adult participants diagnosed with MDD.
METHODS
Adults aged 22-64 with MDD and an inadequate response to antidepressant therapy were included. Participants were randomized to receive CT-152 or a sham digital therapeutic. CT-152 is a smartphone app delivering cognitive-emotional and behavioral interventions, including exercises, lessons, and text messaging. The trial lasted up to 13 weeks and included in-person or remote visits. Efficacy was evaluated using various scales, and adverse events were assessed. Satisfaction and health status were also measured.
RESULTS
The study began in February 2021 and was expected to be completed by October 2022.
CONCLUSIONS
This study protocol is robust and incorporates key aspects of conventional phase 3 trial design. It provides a comprehensive understanding of the effectiveness of CT-152 as an adjunct to antidepressant therapy.
TRIAL REGISTRATION: ClinicalTrials.gov NCT04770285; https://clinicaltrials.gov/study/NCT04770285
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/56960
PMID:39163592 | DOI:10.2196/56960
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