Phase 3 Data Support CT-155 as a Novel Digital Therapeutic for Negative Symptoms in Schizophrenia at ECNP

CONFERENCE REPORTER

Phase 3 data from the CONVOKE study (NCT05838625) of CT-155 demonstrated a statistically significant reduction in negative symptoms in patients with schizophrenia, according to a presentation at the 38th Annual European College of Neuropsychopharmacology (ECNP) Congress in Amsterdam.¹

CONVOKE, a multicenter, double-blind study, included adult patients with schizophrenia (N=464) who were stabilized for positive symptoms but experiencing negative symptoms. Participants were randomized to receive standard of care therapy along with digital therapeutics, either CT-155 (BI 3972080) or a sham digital intervention. Patients, most of whom were also on an antipsychotic, were followed for 16 weeks. Researchers looked at the change in experiential negative symptoms from baseline as measured by the Clinical Assessment Interview for Negative Symptoms, Motivation and Pleasure Scale (CAINS-MAP). “The CAINS-MAP is a second-generation assessment that examines the core deficits that matter to patients and their families,” presenter Abhishek Pratap, PhD, explained to attendees.

Pratap added that the CONVOKE trial was “as rigorous as any drug trial.” Pratap is the global evidence lead of Boehringer Ingelheim, the company developing CT-155, an adjunct faculty member at the University of Washington, Seattle and Boston University, as well as a visiting research fellow at King’s College London.

Treatment via CT-155 resulted in a 6.8-point improvement on the CAINS-MAP vs 4.2 for the control arm, showing statistical significance via Cohen’s D effect size of -0.36 (p=0.0003). Moreover, almost three-quarters (70.4% and 76.5%, respectively) of the patients in both the CT-155 group and the control groups used the app through the end of week 15, demonstrating high engagement. “Seven out of 10 [participants] across both arms were using their app on day 105, which is the last day when the active modules in the app stopped. I have not seen anything in literature [like that] so far,” Pratap said. “This is completely a sea change in that regards. It's an extremely encouraging data for us to see.”

CT-155 demonstrated a good safety profile, with no serious adverse effects and no trial discontinuations associated with it (there were 2 discontinuations in the control group).

“One out of 2 patients with schizophrenia continues to have nontreated negative symptoms,” making negative symptoms “a huge unmet need,” Pratap said. “This is where I believe psychosocial interventions can help bolster real world skills to help them cope with these deficits.”

Although negative symptoms of schizophrenia contribute to poor outcomes, evidence-based psychosocial interventions can improve negative symptoms and quality of life for patients. Unfortunately, access is often an obstacle, and adherence can be tricky. Pratap explained digital therapeutics have the potential to address the unmet need and accessibility issues.

“On every 2 out of 3 days, or 7 out of 10 days, depending on how you look at it, patients are logging in and completing activities,” he said of the trial results. Data indicated that, on average, patients spent about 8 minutes per day on the digital intervention, which is roughly equivalent to an hour of psychotherapy per week addressing negative symptoms, he added.

The digital therapeutic, which received FDA breakthrough device designation in January 2024,² was designed with input from patient groups. “The design and development of CT-155 was informed by an iterative patient-centered 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,” said Austin Speier, Chief Strategy Officer, Click Therapeutics, in a press release following the presentation.³

“The positive primary endpoint results observed from the CT-155 Phase III 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," Gregory W. Mattingly, MD, associate clinical professor at Washington University in St. Louis, MO, and principal investigator in clinical trials for Midwest Research Group and Founding Partner of St. Charles Psychiatric Associates, said in a press release. "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."³

Pratap noted data from the phase 3b trial, which is currently underway, should be available by next year.

References

1. Pratap A. Novel Therapies Symposium: Topline results from CONVOKE: A first-in-class Phase 3 RCT evaluating a digital therapeutic for experiential negative symptoms of schizophrenia in adult. Presented at the 38th European College of Neuropsychopharmacology Congress; Amsterdam, The Netherlands; October 11-14, 2025.

2. O’Brien E. Prescription Digital Therapeutic for Schizophrenia Receives FDA Breakthrough Device Designation. Psychiatric Times. January 4, 2024. Accessed October 13, 2025. https://www.psychiatrictimes.com/view/prescription-digital-therapeutic-for-schizophrenia-receives-fda-breakthrough-device-designation

3. Boehringer and Click Therapeutics present pivotal data for investigational prescription digital therapeutic CT-155 showing a statistically significant reduction in negative symptoms of schizophrenia. Press release. October 13, 2025. Accessed October 13, 2025. https://www.boehringer-ingelheim.com/us/media/press-releases/boehringer-presents-pivotal-data-phase-iii-convoke-study