Medibio DDA Confirmatory Performance Study

NCT03529513 | Completed FDA Device

• 1 other identifier: MB-DEPDX04
• Study Type: observational
• Target: 234
• Locations: 2 countries
• Sites: 8

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.

Conditions

Major Depressive Episode

Outcome Measures

Primary Outcomes (1)

• Measure heart rate variability

  The Medibio Algorithm will process data from subject 24-hour ECG data recordings.

  Up to 2 weeks

Study Arms (2)

Depressed

Subjects currently experiencing a moderate-to-severe major depressive episode are clinically evaluated over approximately 2-week period. 24-hour ECG data recordings are collected during each of the two weeks. Subjects may continue on current treatment regimen.

Diagnostic Test: Medibio Depression Diagnostic Aid; Diagnostic Test: Mini International Neuropsychiatric Interview; Diagnostic Test: Hamilton Rating Scale for Depression - 17 Item

Control

Subjects not currently experiencing a major depressive episode are clinically evaluated over approximately 2-week period. 24-hour ECG data recordings are collected during each of the two weeks. Subjects may continue on current treatment regimen.

Diagnostic Test: Medibio Depression Diagnostic Aid; Diagnostic Test: Mini International Neuropsychiatric Interview; Diagnostic Test: Hamilton Rating Scale for Depression - 17 Item

Interventions

Medibio Depression Diagnostic Aid DIAGNOSTIC_TEST

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.

Control; Depressed

Mini International Neuropsychiatric Interview DIAGNOSTIC_TEST

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.

Also known as: M.I.N.I.

Control; Depressed

Hamilton Rating Scale for Depression - 17 Item DIAGNOSTIC_TEST

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.

Also known as: HAMD-17

Control; Depressed

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who may be currently experiencing an episode of depression that are being diagnosed or treated in a mental health setting.

You may qualify if:

• Subject is willing and able to provide consent.
• Subject has ability to read and understand the instructions for the study.
• Subject is willing to adhere to study procedures.

You may not qualify if:

• Subject has active psychotic symptoms.
• Subject has bipolar disorder.
• Subject has known, or is suspected to have a personality disorder.
• Subject has current suicidality of medium or high risk as determined by M.I.N.I. or HAMD-17 item #3 score of 3 of higher.
• Subject has history of central or obstructive sleep apnea OR STOP-BANG questionnaire score of ≥5.
• Subject has a pacemaker.
• Subject currently uses benzodiazepines on a scheduled basis.
• Subject currently uses chronotropic medication, such as beta-blockers, digoxin, sinoatrial/atrioventricular nodal-acting calcium channel blockers, or amiodarone.
• Subject is suspected or known to have active alcohol or drug abuse (including but not limited to abuse of marijuana).
• Subject has a terminal illness.
• For female subjects, subject is currently known to be pregnant or lactating.
• Subject has any other acute or chronic condition that in the investigators opinion would preclude the subject from being able to meet all of the protocol requirements, or would compromise the subject's safety during participation in the study, as judged by the investigator.
• Subject is currently participating in another clinical study. Subject currently uses antipsychotic medication for any indication.

Sponsors & Collaborators

• Medibio Limited: lead

Study Sites (8)

CNS Network

Garden Grove, California, 92845, United States

Location

CNS Network

Torrance, California, 90502, United States

Location

Lindner Center of HOPE

Mason, Ohio, 45040, United States

Location

OCCI, Inc.

Salem, Oregon, 97301, United States

Location

FutureSearch Trials

Dallas, Texas, 75231, United States

Location

White River Junction Veterans Affairs Medical Center

White River Junction, Vermont, 05009, United States

Location

Epworth Clinic

Camberwell, Victoria, 3124, Australia

Location

The Melbourne Clinic

Richmond, Victoria, 3121, Australia

Location

Study Officials

• Melissa Bruner

  Medibio Limited

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: May 18, 2018
• Study Start: August 18, 2017
• Primary Completion: May 4, 2018
• Study Completion: May 4, 2018
• Last Updated: December 21, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2); US (6)