Q&A: Investigational digital therapeutic may help improve schizophrenia

Key takeaways:

• Click Therapeutics began a clinical trial of an investigational digital therapy for the treatment of schizophrenia symptoms.
• The intervention is an adjunct therapy to standard antipsychotics.

Click Therapeutics announced it has enrolled the first patient in a clinical trial of an investigational prescription digital therapeutic to support standard antipsychotic treatment of schizophrenia, according to a company press release.

Alongside Boehringer Ingelheim, Click Therapeutics plans to ultimately enroll 432 adults with schizophrenia across the United States in the CONVOKE study, according to the release.

Healio spoke with Shaheen Lakhan, MD, PhD, FAAN, chief medical officer of Click Therapeutics, to learn more about the CONVOKE study.

Healio: What prompted this study?

Lakhan: Click Therapeutics champions a biotech approach to R&D and passionately believes in the importance of putting patients first by creating treatments that work. Our partner, Boehringer Ingelheim, shares this commitment and vision to transform mental health care. Together, we are developing a unique therapeutic approach utilizing digital mechanisms of action to create a potential first-in-class treatment for the negative symptoms of schizophrenia.

Healio: Can you describe the treatment being tested?

Lakhan: The investigational prescription digital therapeutics (PDTs) tested in the CONVOKE study are intended as an adjunct treatment to standard-of-care antipsychotic therapy to treat the negative symptoms of schizophrenia in individuals 18 years and older. Negative symptoms are a significant contributor to the burden associated with schizophrenia and are strong predictors of functional impairment; however, these symptoms are not effectively addressed by standard-of-care antipsychotics or any other medication. We see great promise in the development of PDTs to alleviate negative symptoms. We cannot disclose further details of the interventions being evaluated at this time.

Healio: What are the primary endpoints?

Lakhan: We have purposely selected the Clinical Assessment Interview for Negative Symptoms, Motivation and Pleasure Scale (CAINS-MAP) to assess for experiential negative symptoms. The CAINS was developed and validated with the National Institute of Mental Health in response to the limitations of existing treatment and assessment approaches to negative symptoms.

Healio: Once the data are in, what do the next steps look like?

Lakhan: We will make the appropriate determination on next steps on the basis of the data from the study. Together with Boehringer Ingelheim we are committed to improving outcomes for individuals with negative symptoms of schizophrenia.

Healio: Is there anything else you would like to highlight about the CONVOKE study?

Lakhan: Boehringer Ingelheim and Click Therapeutics share a joint vision for tackling diseases with high unmet needs that are not adequately addressed by current treatments. The complexities associated with schizophrenia created the perfect opportunity to explore personalized digital therapeutics with pharmacotherapy to create a truly holistic treatment experience for patients. The CONVOKE study is one of the largest trials evaluating PDTs in schizophrenia to date. Combining the latest advances in behavioral science, clinical research and technology, the PDTs in the study are designed to be integrated into peoples’ lives, providing highly targeted and personalized interventions that break embedded behaviors and introduce sustained behavior changes.

Reference:

• Click Therapeutics and Boehringer Ingelheim initiate pivotal clinical trial of prescription digital therapeutics for the treatment of negative symptoms in schizophrenia. https://www.marketwatch.com/press-release/click-therapeutics-and-boehringer-ingelheim-initiate-pivotal-clinical-trial-of-prescription-digital-therapeutics-for-the-treatment-of-negative-symptoms-in-schizophrenia-2023-05-04. Published May 4, 2023. Accessed May 15, 2023.