Boehringer Ingelheim and Click Therapeutics have reported Phase 3 results showing that their investigational prescription digital therapeutic CT-155 achieved a statistically significant reduction in negative symptoms of schizophrenia when used alongside standard antipsychotic therapy.

The data, presented at the European College of Neuropsychopharmacology Congress, came from the CONVOKE trial, a multicentre study evaluating CT-155 as an adjunctive digital therapy in people living with schizophrenia.

The trial met its primary endpoint, measuring change from baseline in experiential negative symptoms at 16 weeks using the Clinical Assessment Interview for Negative Symptoms – Motivation and Pleasure Scale (CAINS-MAP). Treatment with CT-155 showed a Cohen’s D effect size of -0.36 (p=0.0003), equivalent to a 6.8-point improvement on CAINS-MAP compared with a 4.2-point change in the digital control arm, representing a 62% relative improvement.

Gregory Mattingly, associate clinical professor at Washington University in St Louis and principal investigator at Midwest Research Group, said: “The positive primary endpoint results observed from the CT-155 Phase 3 trial represent an important step forward in exploring how negative symptoms may be better understood, which is an area of long-standing unmet need in mental health care. This research underscores the importance of including innovative approaches in the treatment of schizophrenia. The emergence of prescription digital therapeutics, like CT-155, if approved, may hold the potential for patients to access psychosocial intervention from anywhere.”

More than 70% of participants continued using their assigned app until week 15, with similar engagement levels across both arms. Median activity completion was 76 of 112 study days in the CT-155 arm and 92 days in the digital control group. The sponsors said high adherence in both arms supports that the observed effect was driven by CT-155’s therapeutic content rather than engagement differences.

Emmanuelle Clerisme-Beaty, medical director US at Boehringer Ingelheim, said: “CT-155, which integrates psychosocial interventions delivered using an adaptive goal-setting technique, is the first investigational prescription digital therapeutic to show reduction in experiential negative symptoms of schizophrenia in a pivotal trial. In collaboration with Click Therapeutics, we developed CT-155 aiming to address the dual challenges of accessibility and consistency of psychosocial therapy use for people living with negative symptoms of schizophrenia. We look forward to advancing discussions with regulators with the goal of helping patients.”

CT-155 was well tolerated, with adverse event rates of 8.3% versus 13.4% for the digital control group. There were no discontinuations attributed to CT-155 and no serious events related to treatment.

Austin Speier, chief strategy officer at Click Therapeutics, said: “The design and development of CT-155 was informed by an iterative patient-centred approach with more than 150 people living with schizophrenia, ensuring the therapeutic aimed to address the real-life challenges that people with experiential negative symptoms face, such as lack of motivation, social connection, and ability to feel pleasure. For decades, negative symptoms have represented one of the greatest unmet needs for people living with schizophrenia, and we are proud to be exploring CT-155 as a potential new treatment modality in mental health.”

About 3.7 million adults in the US live with schizophrenia, and roughly 60% experience negative symptoms such as loss of motivation, social withdrawal and diminished ability to feel pleasure. These symptoms are linked with poorer outcomes and increased healthcare costs, yet no US regulatory authority has approved a treatment specifically indicated for negative symptoms.

CT-155 (BI 3972080) delivers interactive psychosocial intervention techniques such as adaptive goal setting, cognitive restructuring and social skills training to support real-world behavioural activation. It is designed for use alongside standard antipsychotic therapy.

Boehringer Ingelheim and Click Therapeutics are also running the Enspirus study, evaluating CT-155 in a real-world setting to assess clinical effectiveness, engagement and healthcare resource use.

CT-155 received Breakthrough Device Designation from the US Food and Drug Administration in 2024.