FDA Grants Clearance to Motivista, the First Authorized Treatment for Negative Symptoms of Schizophrenia

The US Food and Drug Administration (FDA) has granted 510(k) clearance (marketing authorization) for Click Therapeutics’ Motivista, which is a prescription digital therapeutic (PDT) indicated for the treatment of negative symptoms of schizophrenia, as an adjunct to clinician-managed outpatient care, in patients aged 18 years and older with clinically stable positive symptoms. This makes Motivista the first FDA-authorized treatment indicated specifically for the treatment of negative symptoms of schizophrenia in the United States.¹

“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, the 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.”

About Motivista

Treatment with Motivista is delivered through a smartphone and is designed to complement schizophrenia treatment as an adjunct to clinician-managed antipsychotic therapy. This prescription digital therapeutic combines key elements of evidence-based psychosocial therapies with digital methods to treat negative symptoms.

Phase 3 CONVOKE Study

The FDA’s decision was supported by data from the phase 3 CONVOKE study. In this study, investigators evaluated Motivista in patients aged 18 years and older with schizophrenia experiencing negative symptoms. Patients using Motivista achieved significantly greater improvements in negative symptom severity than those using a digital control application. Improvement was measured by CAINS-MAP at 16 weeks, where treatment with Motivista resulted in a 6.8-point improvement 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).² Motivista also demonstrated a favorable safety profile, with no serious treatment-related adverse events reported during the study.

There was 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. In total, participants in the Motivista arm spent approximately 1 hour per week using the treatment, which is comparable with the typical time spent in conventional, in-person psychotherapy.

Results from the study were recently published in JAMA Network Open.³

“These engagement results are encouraging because they suggest a new way to address one of the most challenging aspects of schizophrenia, delivered in a patient friendly format that we expect patients will turn to day-to-day,” said Richard DeNunzio, the chief commercial officer at Click Therapeutics. “By helping patients engage more fully in daily life, Motivista has the potential to create meaningful value for patients, providers, and the health care system. That is the kind of value we believe payers and state Medicaid programs should want to cover, to deliver access to this breakthrough treatment to patients at scale.”

Click is also working on an open-label extension study, that delivers additional results on engagement and durability of effect.

Negative Symptoms

This authorization marks a significant milestone for individuals schizophrenia. While there are existing treatments targeting the positive symptoms of schizophrenia, including hallucinations, delusions, and disorganized thinking, most patients still struggle with negative symptoms, such as low motivation, reduced ability to experience and anticipate pleasure, and social withdrawal. These symptoms can be the most disabling and difficult to treat. Until this point, there have been no FDA-authorized treatments indicated specifically for these negative symptoms.

References

1. FDA clears Motivista (CT-155), the first authorized treatment for negative schizophrenia symptoms. News release. October 5, 2026. Accessed October 7, 2026. https://www.globenewswire.com/news-release/2026/10/05/3374959/0/en/fda-clears-motivista-ct-155-the-first-authorized-treatment-for-negative-schizophrenia-symptoms.html

2. Pratap A, Lakhan SE, Snipes C, et al. Topline results from CONVOKE: a first-in-class phase 3 RCT evaluating a digital therapeutic for experiential negative symptoms of schizophrenia in adults. Abstract presented at: European College of Neuropsychopharmacology Congress 2025; October 11-14, 2025; Amsterdam, the Netherlands. Accessed October 7, 2026. https://cdn.neiglobal.com/content/vsp/2025/fall/cngfa_2025-145.pdf

3. Pratap A, Lakhan SE, Snipes C, et al. A digital therapeutic intervention for negative symptoms of schizophrenia: a randomized clinical trial. JAMA Netw Open. 2026;9(9):e2635753.