Click’s Motivista Receives FDA Clearance for Negative Symptoms of Schizophrenia

The U.S. Food and Drug Administration (FDA) has cleared Click Therapeutics’ Motivista (CT-155), a smartphone-delivered prescription digital therapeutic, through the 510(k) pathway for the treatment of negative symptoms of schizophrenia as an adjunct to clinician-managed outpatient care, including antipsychotic therapy, in adults aged 18 years and older with clinically stable positive symptoms. Click Therapeutics describes Motivista as the first FDA-authorized treatment specifically indicated for negative symptoms of schizophrenia in the United States.

The FDA cleared Motivista on July 30, 2026, after determining that the device was substantially equivalent to a legally marketed predicate device. The predicate was Rejoyn, another prescription digital therapeutic, although Motivista has a different intended use. FDA classified Motivista as a Class II computerized behavioral therapy device for psychiatric disorders under 21 CFR 882.5801.

Motivista CONVOKE Phase III Results

The clearance was supported by results from the Phase III CONVOKE study (NCT05838625), a multicenter, randomized, double-blind, parallel-group clinical trial conducted at 66 sites in the United States. A total of 457 adults with schizophrenia and negative symptoms were randomized to Motivista or a digital control, with 227 participants assigned to Motivista and 230 to the control group. Treatment continued for 16 weeks, followed by a four-week safety follow-up.

The primary endpoint was the change from baseline to week 16 in the Clinical Assessment Interview for Negative Symptoms–Motivation and Pleasure (CAINS-MAP), which assesses experiential negative symptoms involving motivation, pleasure and engagement in activities.

At week 16, the least-squares mean CAINS-MAP score improved by 6.8 points with Motivista compared with 4.2 points with the digital control. The least-squares mean difference was −2.6 points (95% CI, −4.0 to −1.2; p<0.001), favoring Motivista. The Cohen’s d effect size was −0.36 (95% CI, −0.56 to −0.17), indicating a small-to-moderate standardized treatment effect. Click Therapeutics characterized the between-group difference as a 62% relative improvement compared with the digital control.

Engagement and Safety

Most participants remained active users through week 15, with 70.4% of participants receiving Motivista and 76.5% receiving the digital control remaining active. Participants in the Motivista arm spent approximately six minutes per day using the application, equivalent to roughly one hour per week.

Serious adverse events occurred in 3 of 228 participants receiving Motivista (1.3%) and 5 of 231 participants receiving the digital control (2.2%) during the treatment and follow-up periods. None was considered treatment-related. Two non-serious episodes of “psychotic disorder” occurred in one Motivista participant and were considered possibly related by the investigator and medical monitor because of their temporal association with treatment. The sponsor considered the events unrelated and consistent with normal disease fluctuation. Neither event resulted in treatment discontinuation.

Suicidal ideation and behavior were monitored throughout the study. Motivista is not designed for patients presenting a serious suicide risk, including those with active suicidal ideation with method or intent within the previous three months or suicidal behavior within the previous six months. The therapy is also not intended for patients with unmanaged positive symptoms, severe cognitive impairment that prevents independent use, or patients younger than 18 years.

Digital Treatment for Negative Symptoms

Motivista is delivered through a smartphone and combines elements of evidence-based psychosocial therapies with digital treatment methods. The intervention is designed to support motivation, pleasure and goal-directed behavior and was developed with input from patients and clinicians. It is intended to complement, rather than replace, clinician-managed pharmacotherapy for schizophrenia.

Negative symptoms include avolition, anhedonia and asociality, which can affect motivation, the ability to experience or anticipate pleasure, and social engagement. Click Therapeutics estimates that schizophrenia affects approximately 24 million people worldwide and that around 60% of individuals with the condition experience negative symptoms.

Indication and Evidence Considerations

Motivista is indicated as an adjunct to clinician-managed outpatient care, including antipsychotic therapy, in adults with clinically stable positive symptoms. It is not a standalone treatment and is not intended to treat acute schizophrenia symptoms or replace antipsychotic medication.

The CONVOKE trial specifically evaluated experiential negative symptoms and was conducted in patients receiving stable antipsychotic treatment. Therefore, the findings should not be interpreted as evidence that Motivista treats all manifestations of schizophrenia or replaces established pharmacotherapy.

Commercial Availability and Further Evidence

Click Therapeutics said it is preparing Motivista for broader commercial availability and is working with payers, providers and patient advocacy organizations to expand access. The company is also evaluating Motivista in an open-label extension study (NCT06067984) to generate additional information on engagement and durability of treatment effects.

The 16-week CONVOKE results demonstrated a statistically significant improvement in experiential negative symptoms on the primary CAINS-MAP endpoint compared with a digital control. The observed effect was modest in standardized terms, and longer-term evidence will be important for determining the durability of the treatment benefit.

Reference

FDA Clears Motivista (CT-155), the First Authorized Treatment for Negative Schizophrenia Symptoms, Click Therapeutics, 05 October 2026

Study of Two Digital Therapeutics for the Treatment of Experiential Negative Symptoms of Schizophrenia (CONVOKE), ClinicalTrials.gov ID NCT05838625