HANOVER, N.H. — Boehringer Ingelheim has announced plans to submit its innovative app designed to address under-treated symptoms of schizophrenia to the Food and Drug Administration (FDA) for clearance, following promising results from a late-stage clinical trial.
The app, CT-155, developed in collaboration with Click Therapeutics, represents a novel 16-week treatment approach that incorporates key elements of traditional face-to-face psychosocial therapies as an adjunct to existing antipsychotic medications. Schizophrenia, which affects millions in the U.S., is often characterized by psychotic symptoms, but it also presents significant negative symptoms such as anhedonia and avolition, for which no approved pharmacological treatments currently exist.
In the recently reported results from a randomized control trial involving 464 participants, Boehringer Ingelheim demonstrated that users of the CT-155 app showed significant improvements on a validated rating scale for these negative symptoms compared to a control group. The treatment successfully met its primary endpoint, surpassing the pre-established threshold for effect size, indicating its potential impact on a critical area of schizophrenia management.
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