Major Depressive Disorder Clinical Trial
Official title:
A Single Center Pilot Study to Evaluate Real Time Passive and Active High-Frequency Cognitive and Mood Assessment Data in Major Depressive Disorder Using Digital Wearable Technology
The purpose of this study was to evaluate the feasibility and compliance with a novel method for assessing mood and cognition in participants with major depressive disorder (MDD).
The novel method being tested in this study for assessing mood and cognition in participants
with MDD was wearable technology. This study looked at the correlation of mood and cognition
outcomes on wearable technology with traditional objective neuropsychological cognitive
function tests and self-reported mood outcomes.
The study enrolled approximately 30 patients. Participants were provided with a watch on
which brief cognitive and mood tests were evaluated daily up to 6 weeks.
All participants prompted to complete cognitive and mood assessments on 3 occasions across
the day. Two occasions (morning and afternoon) comprised assessment of cognition, and the
final assessment in the evening constituted a review of the day focusing on self-reported
depressed mood.
This single-center trial was conducted in United Kingdom. The overall time to participate in
this study was 6 weeks. Participants took part up to 5 study visits (1 in-person on-site
visit, 3 web-based and 1 at home visit) assessing performance on traditional objective
neuropsychological cognitive function tests and self-reported measures of depression symptom
severity and social function.
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