Digital App Effective for Schizophrenia in Phase 3 Trial

CT-155 (Boehringer Ingelheim and Click Therapeutics), an investigational prescription digital therapeutic, was both safe and effective in reducing negative symptoms of schizophrenia in a new phase 3 trial, its manufacturers announced in a press release.

Top-line results from the CONVOKE trial, which included 464 US adults with schizophrenia, showed that CT-155 plus standard-of-care antipsychotic therapy was associated with significantly reduced negative symptoms between baseline and week 16, meeting the study’s primary endpoint.

CT-155 was well tolerated and demonstrated a favorable safety profile similar to previous studies, the release said.

“The observed clinical benefit on experiential negative symptoms in this study, without additional known safety concerns, marks a critical advancement in understanding how we might address this long unmet need,” Shaheen Lakhan, MD, PhD, chief medical and scientific officer of Click Therapeutics, said in the release.

Unmet Need

Although available treatments have been used to help manage negative symptoms of schizophrenia, there is currently no approved treatment specifically for negative symptoms in the US, the companies noted.

CT-155 was granted Breakthrough Device Designation by the FDA in 2024. So far, it is the only app designed solely for schizophrenia to have received this designation.

Last year, the FDA approved the first new schizophrenia treatment in decades. But research reported earlier this year offered disappointing results from a phase 3 trial of that drug, xanomeline/trospium chloride (Cobenfy, Bristol Myers Squibb).

As reported by Medscape Medical News, this has resulted in many clinicians becoming more open to exploring digital and technical solutions — including at this year’s American Psychiatric Association (APA) annual meeting, where most research poster sessions featured presentations on apps targeting psychiatric conditions, including schizophrenia.

CT-155 is a mobile app-based software designed to address negative symptoms of schizophrenia by providing interactive psychosocial techniques when used alongside standard pharmaceutical treatment. The app needs to be prescribed by a healthcare professional and is then installed onto smartphones.

While the World Health Organization estimates that approximately 24 million people worldwide have schizophrenia, about 60% of them experience negative symptoms.

These types of symptoms involve an absence or reduction of behaviors and functions considered normal, including blunted affect, reduced speech, and social withdrawal. Positive schizophrenia symptoms, on the other hand, are those that add experiences or perceptions, such as hallucinations, delusions, and paranoia.

Detailed Results Coming Soon

CONVOKE is a randomized, double-blind, multicenter, phase 3 trial. Its primary endpoint was reduction in experiential negative symptoms from baseline to week 16, as measured using the Clinical Assessment Interview for Negative Symptoms, Motivation, and Pleasure Scale (CAINS-MAP), for CT-155 vs a digital control app used along with standard-of-care antipsychotic therapy.

Other endpoints, including change from baseline to week 8 on the CAINS-MAP and improvement on the Patient Global Impression of Improvement Scale at weeks 8 and 16 have not been released yet.

However, detailed results from CONVOKE are scheduled to be presented in October at the European College of Neuropsychopharmacology Congress’ Novel Therapeutics Symposium.

Before today’s results were announced, John Torous, MD, psychiatrist and director of Digital Psychiatry at Beth Israel Deaconess Medical Center in Boston, voiced his optimism about the study at the APA meeting and told Medscape Medical News he hoped the product could roll out quickly if it proved to be effective.

After the results were released, he tweeted, “Impressive results for a new app to support people with schizophrenia, given the study features a rigorous digital control group.” Torous added that he is “excited to see such advances in digital health.”

Although he was not involved with the CONVOKE study, Torous reported being a clinical advisor to Boehringer Ingelheim.