Digital Therapeutic Improves Negative Symptoms of Schizophrenia

Digital therapeutics have the potential to reduce experiential negative symptoms (ENS) in patients with schizophrenia, according to poster findings presented at Psych Congress 2023 in Nashville, Tennessee.

“The observed clinical efficacy alongside the benign safety profile encourages further clinical development,” said lead author Brendan Hare, PhD, from Boehringer Ingelheim Pharmaceuticals, Inc.

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Since there are currently no pharmacotherapies that are approved by the US Food and Drug Administration (FDA) for the treatment of ENS, researchers wanted to test the treatment potential of a beta version prescription digital therapeutic: CT-155. The creator of CT-155, Boehringer Ingelheim, describes it as providing “psychosocial intervention techniques to people experiencing negative symptoms of schizophrenia.” The therapeutic is meant to be prescribed by a health care professional and can be installed on a smart phone. 

The study included adults diagnosed with schizophrenia who had Motivation and Pleasure Self-Report [MAP-SR] Scale scores under 30 and had been on a stable antipsychotic dose for at least 12 weeks. Patients had on-demand access to CT-155 throughout the study and engagement was monitored. ENS were assessed with the Clinical Assessment Interview for Negative Symptoms-MAP Scale (CAINS-MAP) at baseline and at the end of the study (7 weeks).

Of the 43 patients who completed the study, 20% were female, 58% were African American, and 64% had no college education. Patients completed an average of 4 of the 4-step goals and 18 therapeutic lessons (out of 21 total). There was a significant reduction (p=0.004) in CAINS-MAP scores after 7 weeks (mean score [standard deviation]=16.8 [7.8]; n=43 versus baseline, 20.2 [8.6]). Authors also reported no serious adverse events related to the use of the therapeutic. 

The study was funded by Boehringer Ingelheim and Click Therapeutics.

Reference
Hare B, et al. Efficacy and engagement with a digital therapeutic in patients with experiential negative symptoms of schizophrenia. Poster presented at Psych Congress; September 6-10, 2023; Nashville, Tennessee.