Prescription Digital Therapeutic CT-155 Promising for Negative Symptoms of Schizophrenia

For patients with schizophrenia experiencing negative symptoms, the addition of an investigational prescription digital therapeutic (PDT) to standard of care (SOC) antipsychotic therapy was found to be beneficial, according to results from a phase 3 study.

The randomized, double-blind, CONVOKE trial (ClinicalTrials.gov Identifier: NCT05838625) evaluated the safety and efficacy of CT-155, a PDT that provides interactive psychosocial intervention techniques via a smartphone app, in adult and late adolescent patients with negative symptoms of schizophrenia who were stable on antipsychotic medication (N=464). 

Study participants were randomly assigned to receive treatment with CT-155 or a digital control app, in addition to SOC. The primary endpoint was the change from baseline to week 16 in experiential negative symptoms, as assessed by the Clinical Assessment Interview for Negative Symptoms, Motivation and Pleasure Scale (CAINS-MAP).

Results showed the study met its primary endpoint demonstrating a significant reduction in experiential negative symptoms with CT-155, as measured by CAINS-MAP at week 16. The PDT was reported to have a favorable safety profile and was well tolerated by participants. 

“Findings from CONVOKE provide the first phase 3 evidence supporting the potential of a prescription digital therapeutic as an adjunct to standard of care antipsychotic therapy to treat a core element of schizophrenia,” said Shaheen Lakhan, MD, PhD, FAAN, chief medical and scientific officer of Click Therapeutics. “The observed clinical benefit on experiential negative symptoms in this study, without additional known safety concerns, marks a critical advancement in understanding how we might address this long unmet need.”

Full results from the trial will be presented at the 38th Annual European College of Neuropsychopharmacology (ECNP) Congress.

This article originally appeared on MPR