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Boehringer Ingelheim and Click Therapeutics’ prescription digital therapeutic CT-155 achieved its primary endpoint in the Phase III CONVOKE trial, significantly reducing experiential negative symptoms of schizophrenia when combined with standard antipsychotics. Over 16 weeks, CT-155 outperformed a control app on CAINS-MAP scores, indicating improved motivation and pleasure without additional safety concerns.
Full results will be shared at the 38th ECNP Congress in October. The partners plan to seek regulatory approval, supported by the FDA’s 2024 breakthrough device designation. If approved, CT-155 would be the first FDA-cleared digital therapy for schizophrenia-related negative symptoms, expanding current treatments that mainly address psychosis and hallucinations.
This advance comes amid broader innovation in schizophrenia care, from dopamine-sparing drugs like BMS’s Cobenfy to research into choline receptor agonists and psychedelics. While many novel approaches face development hurdles, CT-155’s success could mark a pivotal shift in integrating digital therapeutics into psychiatric care.
10-08-2025