Efficacy and Engagement With a Digital Therapeutic in Patients With Experiential Negative Symptoms of Schizophrenia

This work was sponsored by Boehringer Ingelheim and Click Therapeutics. Introduction Negative symptoms are key drivers of the burden associated with schizophrenia. Currently, no pharmacotherapies are FDA-approved for treatment of experiential negative symptoms (ENS). Digital therapeutics may represent a resource for evidence-based care given ubiquitous smartphone ownership. A beta version of a prescription digital therapeutic (CT-155) targeting improvement of ENS was evaluated to inform further development. Methods This exploratory, 7-week study included adults (≥18 years) diagnosed with schizophrenia and ENS (score ≤30 on the Motivation and Pleasure Self-Report [MAP-SR] Scale) on a stable antipsychotic dose (≥12 weeks). Patients had on-demand access to the beta version of CT-155; engagement was measured throughout the study. ENS were assessed with the Clinical Assessment Interview for Negative Symptoms-MAP Scale (CAINS-MAP) at baseline and end of study. Results Of 50 enrolled adults, 43 (86%) completed the study. Most patients were male (80%), black or African-American (58%), and without college education (64%). Patients completed a median of 4 of the 4-step goals and 18 of 21 therapeutic lessons. Of patients that completed a goal, 70% completed ≥4 goals. A significant reduction (p=0.004) in CAINS-MAP scores was evident after 7 weeks (mean score [standard deviation]=16.8 [7.8]; n=43 versus baseline, 20.2 [8.6]). Of 3 adverse events, none were serious or related to use of the beta version of CT-155. Conclusions In patients living with ENS of schizophrenia, use of the beta version of CT-155 significantly reduced ENS. The observed clinical efficacy alongside benign safety profile encourage further clinical development. Funding: Boehringer Ingelheim and Click Therapeutics.