Digital Measures To Advance Research & Quality Of Life In Schizophrenia

Schizophrenia spectrum disorders (hereafter referred to as schizophrenia) are complex and serious psychiatric conditions, characterized by symptoms like hallucinations, delusions, and negative symptoms such as loss of motivation. Beyond these psychiatric symptoms, schizophrenia is also linked to significant functional impairments in areas such as occupational and interpersonal functioning. These impairments stem not only from psychiatric symptoms but also from deficits in cognitive abilities, language and communication disturbances, and changes in physical functioning, including activity levels and sleep patterns. The clinical presentation of schizophrenia is marked by considerable heterogeneity, both between individuals and within the same individual over time, making it challenging to accurately assess and monitor clinical severity and treatment response, particularly in terms of patient-centered outcomes related to real-world functioning and quality of life.

Digital assessment solutions offer a way to overcome the limitations of traditional measures by directly and objectively assessing treatment effects and associated clinical outcomes in daily life. The FDA’s guidance documents underscore the potential of digital health technologies (DHTs) to enhance clinical assessments and emphasize the importance of capturing real-world functioning and quality of life in patient-centered outcomes. DHTs can assess multifaceted aspects of real-world functioning—such as activity patterns, speech, and cognitive functioning—which is particularly important for detecting treatment-related changes in schizophrenia due to its complex and heterogeneous nature. Here, we explore the inherent challenges of traditional clinical assessment in schizophrenia and propose solutions through the use of multi-modal digital assessment technology.