Prescription Digital Therapeutic for Schizophrenia Receives FDA Breakthrough Device Designation


The device is currently under clinical trial investigation as an adjunct treatment to standard of care therapy for experiential negative symptoms of schizophrenia.



The US Food & Drug Administration (FDA) has granted Breakthrough Device designation to an investigational prescription digital therapeutic (PDT) currently under investigation for the treatment of schizophrenia in adult and older adolescent patients.

The PDT is under investigation in the CONVOKE Study (NCT05838625), initiated by Boehringer Ingelheim and Click Therapeutics in 2023. The study is a randomized, multicenter, 16-week clinical trial dedicated to evaluating the efficacy and safety of 2 investigational PDTs and standard of care (SOC) therapy in addressing experiential negative symptoms of schizophrenia. The study aims to bridge existing gaps in care, reach diverse populations, and introduce real-time care management for individuals grappling with experiential negative symptoms of schizophrenia—which remains one of the most complex mental health conditions, presenting unique challenges in treatment.1,2

“Boehringer Ingelheim and Click Therapeutics have a shared vision in our approach to prescription digital therapeutics,” said David Benshoof Klein, CEO of Click Therapeutics, in a statement. “At the core of this is creating a patient-centric design where our digital therapies are created both for and with patients. We believe this will result in an adaptive, personalized treatment to meet patients where they are, potentially leading to high engagement and long-term value.”

In the CONVOKE Study, the PDTs—Digital Therapeutic A and Digital Therapeutic B—are smart phone apps that are each being evaluated for their safety and efficacy as adjunct treatments to SOC. The estimated enrollment is 432 participants aged 18 years and older, with all participants having a primary diagnosis of schizophrenia, being on a stable dose of antipsychotic medication(s), and having received an average score of >2 (moderate to severe) in at least 2 out of 3 Clinical Assessment Interview for Negative Symptoms and Motivation and Pleasure Scale (CAINS-MAP) domains (work, social, or recreational). Exclusion criteria include current treatment with more than 2 antipsychotic medications, past participation in a CT-155 clinical study, and meeting DSM-5 criteria for diagnoses not currently under investigation.2

The study’s primary outcome measure is a change in experiential negative symptoms between baseline and week 16, as measured by CAINS-MAP. Secondary outcome measures include a change in pleasure and motivation symptoms between baseline and week 8 as measured by CAINS-MAP; changes in expressive negative symptoms between baseline, week 8, and week 16, as measured by the CAINS Expressivity Scale (CAINS-EXP); changes in positive symptoms between baseline, week 8, and week 16, as measured by the Positive and Negative Syndrome Scale (PANSS); changes in social functioning between baseline, week 8, and week 16, as measured by the Personal and Social Performance Scale (PSP); changes in self-reported defeatist beliefs between baseline, week 8, and week 16, as measured by the Defeatist Beliefs Subscale of the Dysfunctional Attitudes Scale (DAS); and changes in patient global impression of improvement between weeks 8 and 16, as measured by the Patient Global Impression of Improvement Scale (PGI-I).2

The collaboration between Boehringer Ingelheim and Click Therapeutics also extends beyond the CONVOKE Study, with ongoing development of additional PDTs forming a comprehensive treatment strategy for schizophrenia. PDTs, once FDA cleared, may expand accessibility to evidence-based treatments and be evaluated for reimbursement by health insurance companies.

“Digital therapeutics, which can provide evidence-based psychological and behavioral treatment strategies through a smart phone, are well positioned to overcome many of the access barriers to treatment and may be an effective tool to help address the mental health care crisis,” said David Mohr, PhD, president of the Society for Digital Mental Health, in a statement.

The estimated completion date of the CONVOKE Study is June 6, 2024.2

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Note: This article was prepared with the assistance of ChatGPT.


1. Prescription digital therapeutics a new frontier in mental health care—a personalized treatment that could bridge the access gap. Boehringer Ingelheim. Accessed January 4, 2024.

2. Study of two digital therapeutics for the treatment of experiential negative symptoms of schizophrenia (CONVOKE). Last updated May 1, 2023. Accessed January 4, 2024.

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