Medibio DDA Confirmatory Performance Study

CompletedOBSERVATIONAL
Enrollment

234

Participants

Timeline

Start Date

August 18, 2017

Primary Completion Date

May 4, 2018

Study Completion Date

May 4, 2018

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.

Trial Locations (8)

3121

The Melbourne Clinic, Richmond

3124

Epworth Clinic, Camberwell

45040

Lindner Center of HOPE, Mason

75231

FutureSearch Trials, Dallas

90502

CNS Network, Torrance

92845

CNS Network, Garden Grove

97301

OCCI, Inc., Salem

05009

White River Junction Veterans Affairs Medical Center, White River Junction

All Listed Sponsors
lead

Medibio Limited

INDUSTRY

NCT03529513 - Medibio DDA Confirmatory Performance Study | Biotech Hunter | Biotech Hunter