Formation of a working alliance and potential efficacy of a digital therapeutic to treat experiential negative symptoms of schizophrenia

Abstract: Introduction: Currently, no FDA-approved pharmacological treatments satisfactorily address experiential negative symptoms (ENS) of schizophrenia. CT-155 is a prescription digital therapeutic under investigation for the treatment of ENS. We explored whether patients could establish and maintain a digital working alliance (DWA) with a beta version of CT-155 (CT-155 beta) (Study 1; 3 weeks) and assessed patient 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 patients (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 patients with moderate versus severe ENS. In Study 2, ENS (CAINS-MAP score) were significantly reduced by 17% (p=0.004) after 7 weeks. Patients 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: Patients 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 and Click TherapeuticsShort Description: Currently, no pharmacotherapies are approved for experiential negative symptoms (ENS) of schizophrenia. CT-155 is a prescription digital therapeutic (PDT) under investigation for the treatment of ENS. Two independent exploratory studies investigated a beta version of CT-155 (CT-155 beta). People living with schizophrenia and ENS formed a positive digital working alliance (DWA) with CT-155 beta. ENS were reduced after 7 weeks without safety concerns. These findings support advancing CT-155 into late-phase clinical development.Name of Sponsoring Organization(s): Boehringer Ingelheim and Click Therapeutics