Negative symptoms of schizophrenia, including avolition, anhedonia, and asociality, are major contributors to functional impairment, reduced quality of life, and long-term disability. These symptoms frequently persist despite adequate control of positive symptoms with antipsychotic medications, and treatment options remain limited. On October 5, 2026, Click Therapeutics announced that the US Food and Drug Administration (FDA) had granted 510(k) clearance to Motivista (CT-155), which the company describes as the first FDA-authorized treatment specifically indicated for negative symptoms of schizophrenia. Motivista is a prescription digital therapeutic designed for use as an adjunct to clinician-managed outpatient care, including antipsychotic therapy, in adults aged 18 years and older with clinically stable positive symptoms.

Motivista is a smartphone-based therapeutic that integrates evidence-based psychosocial interventions, including behavioral activation, cognitive restructuring, social skills training, positive affect training, distress tolerance skills, and adaptive goal setting. The intervention is designed to improve motivation, pleasure, and engagement in daily activities through a structured 16-week program. Its FDA clearance was supported by findings from the phase 3 CONVOKE trial, published September 25, 2026, in JAMA Network Open.

CONVOKE was a multicenter, randomized, double-blind, controlled clinical trial conducted at 66 sites across the United States between March 2023 and June 2025. The study enrolled 457 adults with schizophrenia experiencing negative symptoms who were receiving up to two antipsychotic medications, on a stable dose for at least 12 weeks. Participants were randomized 1:1 to receive CT-155 (n=227) or a digital control application (disease-relevant educational lessons) (n=230) for 16 weeks. The primary endpoint was change from baseline to week 16 in the Clinical Assessment Interview for Negative Symptoms, Motivation and Pleasure subscale (CAINS-MAP), which assesses experiential negative symptoms: avolition, anhedonia, and asociality. Secondary endpoints included CAINS-MAP at week 8, expressive symptoms (CAINS-EXP), positive symptoms (PANSS), and the Patient Global Impression–Improvement scale (PGI-I).

At week 16, CT-155 demonstrated significantly greater improvements in motivation and pleasure (experiential) negative symptoms compared with digital control. The least-squares mean change in CAINS-MAP score was −6.8 points with CT-155 versus −4.2 points with digital control, corresponding to a treatment difference of −2.6 points (95% CI, −4.0 to −1.2; P<.001). The effect size was small to moderate (Cohen’s d=−0.36). Improvements were also observed at week 8 (difference −2.5; 95% CI, −3.8 to −1.3; secondary analyses were not adjusted for multiplicity), suggesting that therapeutic benefits emerged before completion of the 16-week intervention. No significant between-group difference was seen at week 16 in expressive symptoms (CAINS-EXP, P=.20) or positive symptoms (PANSS, P=.79), and post hoc analyses indicated that the benefit was concentrated in the Social and Recreational CAINS-MAP subdomains, with none in the Vocational subdomain. Treatment engagement remained relatively high, with 70.4% of CT-155 users and 76.5% of digital control users remaining active through week 15; control participants used their app on more days, whereas CT-155 participants spent more time per day.

CT-155 was generally well tolerated, with no serious treatment-related adverse events reported. Serious adverse events occurred in 1.3% of participants receiving CT-155 and 2.2% receiving digital control, none considered treatment related. One participant in each arm had a non-serious treatment-related adverse event (psychotic symptoms with CT-155; irritability with digital control); in the FDA labeling language, the CT-155 event is described as two events of “psychotic disorder” in a single participant, neither of which led to study discontinuation. Importantly, Motivista is not intended for patients with unmanaged positive symptoms or serious suicide risk and should not replace antipsychotic medications or other clinician-managed treatments. Its safety and effectiveness have not been evaluated in patients younger than 18 years, patients not taking antipsychotic medication, or those with severe cognitive impairment that prevents independent app use.

The FDA authorization of Motivista represents an important development in the treatment of schizophrenia, particularly given the limited therapeutic options specifically targeting negative symptoms. Findings from CONVOKE suggest that a structured digital intervention can produce modest but statistically significant improvements in motivation and pleasure-related symptoms when added to ongoing antipsychotic treatment. However, the clinical significance and long-term durability of these improvements require further evaluation, including their translation into meaningful functional benefits; the trial provided no functional or post-treatment durability data. The trial enrolled participants on stable antipsychotic treatment with smartphone access and stable housing. Motivista may provide an accessible adjunctive treatment option for clinically stable adults with schizophrenia, although its effectiveness in broader clinical populations and routine practice remains to be established.

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