FDA clears Motivista, prescription app for negative symptoms of schizophrenia

FDA has granted 510(k) clearance for Motivista, a prescription smartphone app that delivers a 16-week program of cognitive and behavioral treatment for negative symptoms of schizophrenia. Through lessons, goal-setting activities, and daily check-ins, the app helps patients work toward achievable goals, challenge discouraging thoughts, and practice social skills. It is indicated as an adjunct to clinician-managed outpatient care, including antipsychotic therapy. The authorization makes Motivista the first FDA-authorized treatment specifically indicated for negative symptoms of schizophrenia.

Negative symptoms such as avolition, anhedonia, and social withdrawal are among the most persistent and disabling manifestations of schizophrenia. Although antipsychotic medications can help control hallucinations, delusions, and other positive symptoms, many patients continue to experience substantial functional impairment related to negative symptoms.

FDA's decision was supported by results from the phase 3 CONVOKE trial. Patients using Motivista experienced greater improvement in negative symptom severity than those assigned to a digital control application. At 16 weeks, improvement in motivation and pleasure symptoms was approximately 62% greater with Motivista than with the digital control application. Additional follow-up is ongoing in an open-label extension study evaluating the durability of treatment effects and long-term engagement.

Patient engagement remained high throughout the study, with more than 70% of participants continuing use through week 15. The digital therapeutic was generally well tolerated, with no serious treatment-related adverse events reported. Two episodes of psychotic disorder in a single participant were considered possibly related to treatment but did not lead to study discontinuation.

The product is not intended for use as a standalone therapy, for acute schizophrenia symptoms, or in patients with unmanaged positive symptoms or significant suicide risk.

“For decades, patients living with schizophrenia and the clinicians who care for them have had few options for addressing negative symptoms, despite the profound impact these symptoms can have on everyday life,” said David Benshoof Klein, founder and CEO of Click Therapeutics. “This FDA authorization represents an important step forward for a patient population that has long been underserved and demonstrates the potential of new digital treatment approaches to address some of the most persistent challenges associated with schizophrenia.”

Sources: Click Therapeutics. (2026 Oct 05). FDA Clears Motivista (CT-155), the First Authorized Treatment for Negative Schizophrenia Symptoms; Pratap A, et al (2026 Sept 25) JAMA. A Digital Therapeutic Intervention for Negative Symptoms of Schizophrenia: A Randomized Clinical Trial