Digital Therapeutic CT-155 Improves Negative Symptoms in Schizophrenia: JAMA

A new study published in the Journal of American Medical Association showed that the digital therapy CT-155 enhanced the negative symptoms of schizophrenia, especially in terms of motivation and pleasure, showing a slight to moderate impact similar to established psychological and drug treatments.

Negative symptoms of schizophrenia play a significant role in causing unfavorable results, yet no medications approved by the US Food and Drug Administration are specifically prescribed for treating them. Among these symptoms, lack of motivation and pleasure can be particularly challenging for individuals with schizophrenia. While psychosocial treatments can be helpful, issues with accessibility and maintaining engagement can limit their effectiveness. Digital therapeutics present a new approach for providing patient-focused interventions.

CT-155/BI 3972080 (CT-155) is an experimental digital therapeutic app for smartphones that combines proven psychosocial strategies, aiming to address negative symptoms of schizophrenia along with medication. This research assessed the safety and effectiveness of CT-155 as a complement to medication for managing negative symptoms of schizophrenia.

The CONVOKE study was a phase 3 clinical trial that took place from March 31, 2023, to June 20, 2025, at 66 medical centers in the United States. This trial involved adults experiencing negative symptoms of schizophrenia and taking a maximum of 2 antipsychotic medications.

The main objective was to assess the alteration in the Clinical Assessment Interview for Negative Symptoms, Motivation and Pleasure subscale (CAINS-MAP) score from the beginning to week 16. Secondary goals included changes in Positive and Negative Syndrome Scale positive subscale scores during the same period. All analyses, including baseline characteristics, effectiveness, and engagement, were carried out on the intention-to-treat set.

Out of 457 participants who were randomly selected (average age, 45.8 years; 60.6% male), the retention rate until week 15 was 70.4% for CT-155 and 76.5% for the digital control group. By week 16, CT-155 notably enhanced CAINS-MAP total scores in comparison to the digital control (mean difference, −2.6; 95% confidence interval, −4.0 to −1.2; P-value less than .001; Cohen's d, −0.36).

Serious adverse events were experienced by 1.3% and 2.2% of participants, respectively, with none being linked to the treatment. Overall, the outcomes of this randomized clinical study indicate that CT-155, a digital therapeutic under investigation, is a successful and well-received treatment for adults diagnosed with schizophrenia.

Reference:

Pratap, A., Lakhan, S. E., Snipes, C., Tang, W., Besedina, O., Dickerson, F., Kahn, R. S., Lindenmayer, J.-P., Winderbaum Fernandez, J., Mattingly, G. W., Torous, J., Strauss, G. P., Speier, A., von der Goltz, C., & Dorner-Ciossek, C. (2026). A digital therapeutic intervention for Negative Symptoms of schizophrenia: A randomized clinical trial: A randomized clinical trial. JAMA Network Open, 9(9), e2635753. https://doi.org/10.1001/jamanetworkopen.2026.35753