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News
The FDA has cleared Motivista, the first-ever prescription digital therapeutic (PDT) targeting the negative symptoms of schizophrenia — think avolition, anhedonia, and asociality — symptoms that current antipsychotics largely leave untreated. The smartphone app is used for ~10 minutes daily over 16 weeks as an add-on to standard antipsychotic therapy. In the phase 3 CONVOKE trial, Motivista delivered a 62% relative reduction in experiential negative symptoms compared to a digital control.
The FDA has granted 510(k) clearance to Motivista (CT-155), a prescription digital therapeutic (PDT) developed by Click Therapeutics — making it the first FDA-authorized treatment specifically targeting the negative symptoms of schizophrenia. While existing antipsychotics manage positive symptoms like hallucinations and delusions, negative symptoms such as avolition (lack of motivation), anhedonia (inability to feel pleasure), and asociality have long lacked effective, accessible treatments. Motivista fills that gap by delivering CBT-based techniques — including cognitive restructuring, behavioral activation, and positive affect training — via a smartphone app, designed for about 10 minutes of daily use over 16 weeks.
The clearance was backed by the randomized, double-blind phase 3 CONVOKE trial (N=457), which showed Motivista users significantly outperformed the digital control group on the CAINS-MAP scale, a standard measure of experiential negative symptoms. Adherence was strong, with over 70% of users staying on track through week 15, and the safety profile was favorable with no treatment-related serious adverse events.
By the Numbers:
Why it matters: About 60% of people with schizophrenia experience negative symptoms that persist even when positive symptoms are controlled — driving higher healthcare costs and poorer quality of life. Motivista offers a scalable, patient-friendly option that can reach patients at home, potentially bridging the gap left by limited access to in-person psychosocial care.
