FDA Approves Motivista for Treatment of Negative Symptoms in Schizophrenia

NEW YORK, Oct. 05, 2026 /CourierPR/ -- Click Therapeutics, Inc., has achieved a significant milestone with the U.S. Food and Drug Administration (FDA) granting 510(k) clearance for its digital therapeutic, Motivista, making it the first authorized treatment for negative symptoms of schizophrenia in the United States.

Motivista is designed to complement traditional antipsychotic therapy as an adjunct to clinician-managed outpatient care. The digital therapeutic is intended for patients 18 years of age and older with clinically stable positive symptoms. According to the company, negative symptoms of schizophrenia, such as low motivation, reduced ability to experience pleasure, and social withdrawal, significantly impact the daily lives of millions of people living with the condition. Approximately 60% of individuals with schizophrenia experience these symptoms, which often persist even when other aspects of the disease are well-controlled.

The FDA's decision was supported by data from the Phase III CONVOKE study (NCT05838625), which evaluated Motivista in patients 18 years of age and older with schizophrenia experiencing negative symptoms. Results from the study, recently published in JAMA Network Open, showed that patients using Motivista achieved significantly greater improvements in negative symptom severity compared to those using a digital control application. Specifically, patients using Motivista saw a 6.8-point improvement in negative symptom severity, compared to a 4.2-point improvement in the digital control arm, representing a 62% relative improvement (least square means; Cohen's D effect size of -0.36; p=0.0003).

Motivista is delivered through a smartphone and is designed to complement schizophrenia treatment as an adjunct to clinician-managed antipsychotic therapy. Developed in partnership with patients and clinicians, the therapeutic combines key elements of evidence-based psychosocial therapies with unique digital methods to address negative symptoms. Even though the negative symptoms of schizophrenia make it hard for patients to feel motivated, Motivista’s patient-centric design resulted in strong patient engagement and adherence. Data from the Phase III CONVOKE study showed high sustained app usage through the end of the trial, with 70.4% of Motivista users and 76.5% of digital control users maintaining strong adherence through week 15.2 In total, participants in the Motivista arm spent approximately an hour per week using the treatment, which is comparable to the typical time spent in conventional, in-person psychotherapy.

Schizophrenia affects an estimated 24 million people worldwide, and approximately 60% of individuals living with the condition experience negative symptoms.1,3 These symptoms often persist even when other aspects of the disease are well-controlled and are associated with higher healthcare utilization, increased costs, and poorer long-term outcomes.4

Motivista is currently being prepared for broader commercial availability, and Click Therapeutics is actively working with payers, providers, and patient advocacy organizations to expand access to the treatment. The company is also building a growing body of long-term evidence, including an open-label extension (OLE, NCT06067984) study, that delivers additional results on engagement and durability of effect.