Medibio DDA Confirmatory Performance Study

Status Completed

Clinical Trial Summary

This study will determine whether the Medibio Depression Diagnostic Aid exceeds minimally acceptable thresholds for sensitivity and sensitivity in cases with a current depression episode and non-depressed controls.

Clinical Trial Description

Subjects meeting study criteria will be enrolled into one of two study cohorts: a) outpatient individuals with current, moderate-to-severe major depressive episode (experimental group) and b) individuals without current major depressive episode that have been matched at the group level for age and gender (control group). All subjects will undergo two separate psychiatric interviews to confirm current depression episode presence or absence. Thereafter subjects will wear a heart rate monitor on the chest to capture data over the course of 72 hours. Subjects will return approximately 1 week after initial placement of the monitor for equipment return and a safety check. Subjects will wear a heart-rate monitor over the course of 72 hours. Subjects will return within a week from the last visit for equipment return. ;

Study Design

Related Conditions & MeSH terms

Major Depressive Episode

Clinical Trial Details

NCT number	NCT03529513
Study type	Observational
Source	Medibio Limited
Contact
Status	Completed
Phase
Start date	August 18, 2017
Completion date	May 4, 2018

View Details

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