Enhancing Major Depressive Disorder Research with Wearable DHTs
Durg development in Major Depressive Disorder (MDD) faces several challenges, including high placebo response rates and a heterogeneous patient population that can make it challenging to demonstrate the efficacy of new treatments. Symptom expression in MDD is variable, often characterized by episodes of relapse and remission.
With the advent of sensor-based digital health technologies (DHTs), we now have an unprecedented opportunity to remotely and continuously assess how study participants in MDD research function in their daily lives.
This digital endpoints guide provides information on wearable DHT use in MDD clinical trials and relevant regulatory guidance, a list of digital endpoints available for MDD trials, and research to support the use of wearable DHTs in MDD trials in areas strongly associated with depression, including physical activity, circadian rhythms, and sleep patterns. Opportunities using DHTs include:
- Accurately assessing changes in function in patients with MDD through continuous, objective data
- Collecting evidence of health benefits for MDD trials through novel digital endpoints
- More reliably characterizing patients' symptoms to identify subgroups to support enrollment
- Supporting patient-centric drug development with easy-to-use wrist-worn technology
- Passively examining physical activity, gait and mobility, sleep behavior, circadian rhythms, and vital signs in the patient’s natural environment
Advancing Obesity Research with Digital Measures
Learn more about how medical-grade wearable DHTs can help researchers and drug developers capture objective, continuous data on physical activity, physical functioning, and sleep to fill existing gaps in obesity clinical research: