Ignite Creation Date:
2024-05-06 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 12:46 PM
Study NCT ID:
NCT03529513
Status:
COMPLETED
Last Update Posted:
2023-12-21
First Post:
2018-01-29
Brief Title:
Medibio DDA Confirmatory Performance Study
Sponsor:
Medibio Limited
Organization:
Medibio Limited
Study Overview
Official Title:
Medibio Depression Diagnostic Aid Confirmatory Performance Study
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None