Formation of a Working Alliance and Potential Efficacy of a Digital Therapeutic to Treat Experiential Negative Symptoms of Schizophrenia

Introduction: Currently, no FDA-approved pharmacological treatments satisfactorily address experiential negative symptoms (ENS) of schizophrenia. CT-155/BI 3972080 (CT-155 beta), is a prescription digital therapeutic under development for ENS treatment.

Aims: To explore whether a digital working alliance (DWA) could be established and maintained between participants and CT-155 beta (Study 1; 3 weeks), assessing participant engagement and the impact of CT-155 beta on ENS (Study 2; 7 weeks).

Methods: Two independent, single-arm, multicenter, exploratory studies were conducted in adults with ENS of schizophrenia receiving stable antipsychotics (≥12 weeks) with daily access to CT-155 beta on their smartphones throughout the two studies. DWA was assessed via the validated mobile Agnew Relationship Measure (mARM). ENS were assessed with the Clinical Assessment Interview for Negative Symptoms Motivation and Pleasure Scale (CAINS-MAP).

Results: Overall, 46/49 participants (94%) completed Study 1 and 43/50 (86%) completed Study 2. A positive DWA (mARM score) was established and maintained with CT-155 beta in both studies within 3 weeks. In Study 1, mARM scores positively correlated with number of sessions completed (r2=0.4, p=0.01) and were similar in participants with moderate versus severe ENS. In Study 2, ENS (CAINS-MAP score) were significantly reduced by 17% (p=0.004) after 7 weeks. Participants engaged with CT-155 beta, irrespective of ENS severity. There were 3 non-serious and non-treatment-related adverse events reported in Study 2.

Conclusion: Participants with schizophrenia and ENS reported establishment of a DWA with a DTx, that was associated with improved ENS without any safety concerns.

Funding: Boehringer Ingelheim Pharmaceuticals, Inc./Click Therapeutics