FDA Authorized First Digital Therapy for Schizophrenia
The Motivista smartphone application has been cleared as an adjunct treatment for negative symptoms of schizophrenia.
Updated on Oct. 5, 2026 in Mental Health
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The U.S. Food and Drug Administration has granted 510(k) marketing authorization to Motivista, marking the first prescription digital therapeutic approved for negative schizophrenia symptoms. The treatment is intended for patients 18 and older who have clinically stable positive symptoms.
Why it matters
Negative symptoms, such as social withdrawal and low motivation, are notoriously difficult to treat and affect 60% of schizophrenia patients. This digital tool offers a new approach to managing these symptoms as an adjunct to standard outpatient care.
In the Phase III CONVOKE study, Motivista users saw a 6.8-point improvement on the CAINS-MAP scale, reflecting a 62% relative improvement compared to the control group over 16 weeks. The treatment is indicated for stable patients aged 18 and older.
The players
U.S. Food and Drug Administration
The federal agency responsible for protecting public health by ensuring the safety and efficacy of medical devices and drugs.
Click Therapeutics
The digital health company that developed Motivista and plans to facilitate its commercial availability.
The details
Delivered through a smartphone application, the therapeutic integrates psychosocial therapies with digital methods to address persistent negative symptoms. The study reported no serious treatment-related adverse events among the participants.
Timeline
The FDA granted marketing authorization for Motivista on October 05, 2026.
The clinical improvement was measured over a 16-week period during the study.
The Big Picture
This FDA authorization follows the clinical results established by the Phase III CONVOKE study. The approval marks a significant shift in the medical management of schizophrenia by integrating digital interventions into standard clinical care pathways.
Patients aged 18 and older who are clinically stable may soon be able to access this prescription application as an adjunct to their current treatment plan. The tool is designed to be used alongside clinician-managed outpatient care to address specific negative symptoms.
The takeaway
The approval of this digital therapeutic highlights the growing role of software-based tools in managing complex psychiatric conditions. Patients should consult with their healthcare providers to determine if this new digital adjunct is appropriate for their specific treatment goals.
Further reading
Learn more about the latest innovations in Mental Health.
More information
For more information on the application and clinical study results, visit the Motivista official information site.
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