FDA Authorizes First Digital Therapeutic for Negative Symptoms of Schizophrenia
Key Clinical Summary
- The US Food and Drug Administration (FDA) granted 510(k) clearance for Motivista, the first treatment specifically authorized for negative symptoms of schizophrenia in adults.
- In the phase 3 CONVOKE trial, Motivista significantly improved negative symptom severity compared with a digital control application at 16 weeks (6.8 vs 4.2 points; P = .0003).
- Motivista is indicated as an adjunct to clinician-managed outpatient care, including antipsychotic therapy, in adults aged 18 years or older with clinically stable positive symptoms.
The FDA has granted 510(k) clearance to Motivista, a prescription digital therapeutic developed by Click Therapeutics for the treatment of negative symptoms of schizophrenia in adults. According to the company, Motivista is the first FDA-authorized treatment in the United States specifically indicated for negative symptoms, including avolition, anhedonia, and asociality.
FDA Authorization and Clinical Trial Findings
The smartphone-based prescription digital therapeutic is intended to complement clinician-managed outpatient care, including antipsychotic treatment, in adults with schizophrenia whose positive symptoms are clinically stable.
The authorization was supported by findings from the phase 3 CONVOKE trial (NCT05838625), recently published in JAMA Network Open. The study evaluated Motivista against a digital control application in adults aged 18 years or older experiencing negative symptoms of schizophrenia.
At 16 weeks, patients receiving Motivista demonstrated significantly greater improvement in negative symptom severity, measured using the Clinical Assessment Interview for Negative Symptoms–Motivation and Pleasure (CAINS-MAP) scale, compared with controls.
The Motivista group achieved a 6.8-point improvement versus 4.2 points in the control group, demonstrating a 62% relative improvement (least-squares means; Cohen d = −0.36; P = .0003).
Treatment engagement remained high, with 70.4% of Motivista users and 76.5% of control participants maintaining strong adherence through week 15. Participants receiving Motivista spent approximately 1 hour weekly using the application.
No serious treatment-related adverse events were reported, though 2 events of psychotic disorder in 1 participant were considered possibly related to Motivista by investigators.
Clinical Implications
Negative symptoms affect approximately 60% of individuals with schizophrenia and can impair motivation, social functioning, and participation in daily activities. The authorization introduces an adjunctive treatment specifically indicated for these symptoms, which often persist despite management of positive symptoms.
However, the digital therapeutic is not intended as standalone therapy or for acute schizophrenia symptoms. Its safety and effectiveness have not been evaluated in patients with unmanaged positive symptoms, serious suicide risk, or those not receiving antipsychotic medication.
Looking Ahead
“For decades, patients living with schizophrenia and the clinicians who care for them have had few options for addressing negative symptoms,” said David Benshoof Klein, founder and CEO of Click Therapeutics.
Klein described the FDA authorization as an important development for an underserved population and highlighted the potential of digital approaches to address the persistent symptoms of schizophrenia.
As Motivista is prepared for commercial availability, the company is also conducting an open-label extension study (NCT06067984) to gather additional evidence on long-term engagement and effect durability.
