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Medibio DDA Confirmatory Performance Study

NCT03529513 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 234

Last updated 2023-12-21

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Medibio Limited

    lead INDUSTRY

Principal Investigators

  • Melissa Bruner · Medibio Limited

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-18
Primary Completion
2018-05-04
Completion
2018-05-04
FDA Device
Yes

Countries

  • United States
  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03529513 on ClinicalTrials.gov