STAT+: Boehringer Ingelheim prepares schizophrenia app for FDA submission after trial results

HANOVER, N.H. — Boehringer Ingelheim this week provided more details about a late stage clinical trial of an app designed to treat under-addressed symptoms of schizophrenia and revealed the company is preparing to submit the app to the Food and Drug Administration for clearance.

Developed with Click Therapeutics, the app, CT-155, is a 16-week treatment that adapts key elements of established face-to-face psychosocial treatments for schizophrenia as an adjunct to antipsychotic drug treatment. Schizophrenia affects millions of people in the U.S. and is commonly associated with psychotic behavior and delusions. However, there are other common and often serious negative symptoms, including lack of motivation and the inability to experience pleasure, for which there are no approved drugs.

In the topline results of a 464-participant randomized control trial first released in October, Boehringer Ingelheim said that users of the experimental app improved on a rating scale for these symptoms compared to a group that used a control app. Importantly, the treatment met its primary endpoint by passing a prespecified threshold for effect size. 

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