Shots:
FDA granted 510(k) clearance to Motivista (CT-155), a prescription digital therapeutic for treating negative symptoms of schizophrenia as an adjunct to clinician-managed outpatient care, incl. antipsychotic therapy, in pts (≥18yrs.) with clinically stable positive symptoms
Clearance was supported by the P-III (CONVOKE) trial assessing CT-155 vs a digital control app in pts (≥18yrs.) with…
Shots:
The P-III (CONVOKE) trial assessed CT-155 (BI 3972080) vs a digital control app as an adjunct to SoC antipsychotic therapy in pts (≥18yrs.) with experiential negative symptoms of schizophrenia
Trial met its 1EP with 6.8 vs 4.2-point improvement in negative symptom severity on the CAINS-MAP at 16wks., achieving a Cohen’s D of -0.36; most…

