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This phase 3 CONVOKE trial evaluated CT-155, a digital therapeutic designed to improve motivation and pleasure-related negative symptoms in adults with schizophrenia receiving antipsychotic treatment. The multicentre, double-blind trial randomized 457 participants at 66 US clinical sites to CT-155 (n = 227) or a digital control (n = 230) for 16 weeks. The primary outcome was change in the Motivation and Pleasure subscale of the Clinical Assessment Interview for Negative Symptoms (CAINS-MAP). At week 16, the mean score decreased by 6.8 points with CT-155 compared with 4.2 points with the digital control, producing a between-group difference of −2.6 points (95% CI, −4.0 to −1.2; P < 0.001; Cohen’s d = −0.36), indicating a small-to-moderate treatment effect. Serious adverse events occurred in 3/228 participants (1.3%) receiving CT-155 and 5/231 (2.2%) receiving the digital control; none were considered treatment-related. The intervention did not significantly improve the separate experiential negative-symptom measure or positive symptoms, highlighting the specificity of the observed benefit. Conclusion: CT-155 may provide a useful adjunct to standard pharmacotherapy for motivation- and pleasure-related negative symptoms, although the effect was modest and further evidence is needed regarding long-term functional benefits and real-world implementation.
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This phase 3 CONVOKE trial evaluated CT-155, a digital therapeutic designed to improve motivation and pleasure-related negative symptoms in adults with schizophrenia receiving antipsychotic treatment. The multicentre, double-blind trial randomized 457 participants at 66 US clinical sites to CT-155 (n = 227) or a digital control (n = 230) for 16 weeks. The primary outcome was change in the Motivation and Pleasure subscale of the Clinical Assessment Interview for Negative Symptoms (CAINS-MAP). At week 16, the mean score decreased by 6.8 points with CT-155 compared with 4.2 points with the digital control, producing a between-group difference of −2.6 points (95% CI, −4.0 to −1.2; P < 0.001; Cohen’s d = −0.36), indicating a small-to-moderate treatment effect. Serious adverse events occurred in 3/228 participants (1.3%) receiving CT-155 and 5/231 (2.2%) receiving the digital control; none were considered treatment-related. The intervention did not significantly improve the separate experiential negative-symptom measure or positive symptoms, highlighting the specificity of the observed benefit. Conclusion: CT-155 may provide a useful adjunct to standard pharmacotherapy for motivation- and pleasure-related negative symptoms, although the effect was modest and further evidence is needed regarding long-term functional benefits and real-world implementation.
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