NCT03529513

Medibio DDA Confirmatory Performance Study

Medibio Depression Diagnostic Aid Confirmatory Performance Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 234 (actual)
• Sponsor: Medibio Limited · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Major Depressive Episode

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Medibio Depression Diagnostic Aid	The Medibio DDA processes the heart rate and actigraphy data from the third-party devices, characterizes these data in comparison to the benchmark patterns of persons currently experiencing a depressive episode.
DIAGNOSTIC_TEST	Mini International Neuropsychiatric Interview	The Mini International Neuropsychiatric Interview (M.I.N.I.) is a structured diagnostic interview that was developed as a simple tool to assist clinicians to conduct psychiatric diagnoses according to the DSM-IV and International Statistical Classification of Diseases and Related Health Problems tenth revision (ICD-10) criteria.
DIAGNOSTIC_TEST	Hamilton Rating Scale for Depression - 17 Item	The clinician-administered Hamilton Depression Rating Scale (also known as the HAM-D) is the most widely used depression assessment scale . The original version contains 17 items (HDRS17) pertaining to symptoms of depression experienced over the past week. There are numerous versions with varying lengths that include the HDRS21, HDRS24, and HDRS29. This study will utilize the HDRS17 (HAMD-17) version.

Timeline

• Start date: 2017-08-18
• Primary completion: 2018-05-04
• Completion: 2018-05-04
• First posted: 2018-05-18
• Last updated: 2023-12-21

Locations

8 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated device study