FDA Grants Breakthrough Device Designation to Prescription Digital Therapeutic App for Schizophrenia


The CONVOKE study is investigating the effectiveness of the smartphone app as a therapy for negative symptoms of schizophrenia among adults.

Click Therapeutics’ prescription digital therapeutic (PDT) CT-155 recently received Breakthrough Device designation from the FDA.1

The smartphone app, co-developed by Boehringer Ingelheim, is currently under investigation in the CONVOKE (NCT05838625) study as a pharmaceutical therapy, aiming to address the negative symptoms associated with adult schizophrenia.

CONVOKE, a randomized, multicenter, 16-week study, evaluates the efficacy and safety of two prescription digital therapeutics in addition to standard of care (SOC) therapy for the treatment of experiential negative symptoms of schizophrenia in late adolescence and adults.

The PDT is one of multiple digital therapeutics under joint-development by Click and Boehringer for schizophrenia treatment.

The Breakthrough Devices Program is meant for devices with the potential to offer more effective treatment than existing methods of care for life-threatening diseases. Its purpose is to move the process along of creating and checking new medical devices that meet the criteria for being considered breakthroughs in the US.

Shaheen Lakhan, MD, PhD, FAAN, chief medical officer of Click Therapeutics, said the breakthrough designation brings the team a step closer in providing additional treatment options to those with schizophrenia, while there remains a “significant unmet need due to a lack of access to psychosocial intervention therapies.”1

Lakhan added that their approach is on track to be the industry’s first-in-class treatment for the negative symptoms of schizophrenia.

Schizophrenia is one of the 15 leading causes of disability worldwide, which impacts around 24 million people today, according to a release from Click.1

Schizophrenia also holds as the highest cost per patient of all mental health disorders.

There are currently medications available for “positive” symptoms of schizophrenia including hallucinations, disorganized speech and behavior agitation.

However, a larger burden associated with schizophrenia is the “negative” symptoms, which indicates cognitive impairment and aren’t effectively addressed by the SOC antipsychotic or any other medications.

According to a passage shared by Boehringer Ingelheim, people experiencing negative symptoms of schizophrenia often lack consistent and easily accessible therapy that specifically addresses those symptoms and can be socially isolated or disconnected from everyday life.

Additionally, the passage stated that PDTs can contribute to the improvements of mental health care as the growing mental health crisis demands innovative solutions that can be customized to the person’s symptoms and situation.

The CT-155 program has achieved all development milestones and generated supportive data across multiple clinical learning studies since being in effect in 2020.

The initiation of the CONVOKE trial began in May 2023 and is estimated to be complete by June 6, 2024.

This article originally appeared in Managed Healthcare Executive.

1. Click Therapeutics and Boehringer Ingelheim announce FDA Breakthrough Device Designation for prescription digital therapeutic to treat negative symptoms of schizophrenia. News release. Click Therapeutics. https://www.clicktherapeutics.com/press/click-therapeutics-and-boehringer-ingelheim-announce-fda-breakthrough-device
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