An Observational Pilot Study using a Digital Phenotyping Approach in Patients with Major Depressive Disorder Treated with Trazodone

Abstract

This 8-week study was designed to explore any correlation between a passive data collection approach using a wearable device (i.e., digital phenotyping), active data collection (patient's questionnaires), and a traditional clinical evaluation [Montgomery-Åsberg Depression Rating Scale (MADRS)] in patients with major depressive disorder (MDD) treated with trazodone once a day (OAD). Overall, 11 out of 30 planned patients were enrolled. Passive parameters measured by the wearable device included number of steps, distance walked, calories burned, and sleep quality. A relationship between the sleep score (derived from passively measured data) and MADRS score was observed, as was a relationship between data collected actively (assessing depression, sleep, anxiety, and warning signs) and MADRS score. Despite the limited sample size, the efficacy and safety results were consistent with those previously reported for trazodone. The small population in this study limits the conclusions that can be drawn about the correlation between the digital phenotyping approach and traditional clinical evaluation; however, the positive trends observed suggest the need to increase synergies among clinicians, patients, and researchers to overcome the cultural barriers toward implementation of digital tools in the clinical setting. This study is a step toward the use of digital data in monitoring symptoms of depression, and the preliminary data obtained encourage further investigations of a larger population of patients monitored over a longer period of time.

Keywords: active data collection; digital phenotyping; major depressive disorder; mental health; passive data collection; trazodone.

Figure 1

Scatter plots of passive data by study week (mITT Population). (A) Distance traveled (m); (B) step count; (C) calories burned (kilocalories); (D) duration of deep sleep period (hours); (E) duration of light sleep period (hours); (F) duration of awake sleep period (hours); (G) wake-up count; and (H) duration of sleep. Study Week 1 lasted from Study Day 1 to Study Day 7. The following weeks are multiples of 7 study days. The plotted value is the average of each study week. mITT Population = all patients from the Safety population who additionally have at least 1 day with tracked passive data per week during at least 4 study weeks.

Figure 2

Scatter plot of sleep score by study week (mITT Population). The sleep score measures sleep quality, and ranges from 0 to 100. Higher scores indicate better sleep quality.

Figure 3

Scatter plots of active data by study week (mITT Population). (A) Depression score; (B) sleep score; (C) warning signs score; (D) anxiety score; and (E) medication intake score. If there were no missing active data, the surveys were assigned to study weeks chronologically. Otherwise, Study Week 1 was assigned for the assessment collected at target date Study Day 1 ±3 days. The following study weeks are assigned in multiples of 7 days (with ±3 days at end date as window) from Study Week 1. All scale dimensions scores are the sum of the corresponding items with higher values indicating a worse outcome. mITT Population = all patients from the Safety population who additionally have at least 1 day with tracked passive data per week during at least four study weeks.

Figure 4

Correlation between passive data and MADRS score (mITT Population). MADRS, Montgomery Äsberg Depression Rating Scale; CFB, Change from Baseline. (1) Correlation between MADRS score at Baseline (defined as the value obtained in the Day 0 visit) and averaged passive data from Study Week 1. (2) Correlation between MADRS score at Follow-up and averaged passive data from Study Week 8. (3) Correlation between MADRS score change from baseline at Follow-up and averaged passive data change from Study Week 1 from Study Week 8. (4) The sleep score which measures sleep quality, and ranges from 0 to 100. Higher scores indicate better sleep quality. mITT Population = all patients from the Safety population who additionally have at least 1 day with tracked passive data per week during at least 4 study weeks.

Figure 5

Correlation between active data and MADRS score (mITT Population). MADRS, Montgomery Äsberg Depression Rating Scale; CFB, Change from Baseline. (1) Correlation between MADRS score at Baseline (defined as the value obtained in the Day 0 visit) and active data from Study Week 1. (2) Correlation between MADRS score at Follow-up and active data from Study Week 8. (3) Correlation between MADRS score change from baseline at Follow-up and active data change from Study Week 1 from Study Week 8. mITT Population = all patients from the Safety population who additionally have at least 1 day with tracked passive data per week during at least 4 study weeks.