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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03529513




Registration number
NCT03529513
Ethics application status
Date submitted
29/01/2018
Date registered
7/05/2018
Date last updated
7/05/2018

Titles & IDs
Public title
Medibio DDA Confirmatory Performance Study
Scientific title
Medibio Depression Diagnostic Aid Confirmatory Performance Study
Secondary ID [1] 0 0
MB-DEPDX04
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depressive Episode 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Diagnosis / Prognosis - Medibio Depression Diagnostic Aid
Diagnosis / Prognosis - Mini International Neuropsychiatric Interview
Diagnosis / Prognosis - Hamilton Rating Scale for Depression - 17 Item

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.

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.


Diagnosis / Prognosis: 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.

Diagnosis / Prognosis: 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.

Diagnosis / Prognosis: 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.

Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Measure heart rate variability - The Medibio Algorithm will process data from subject 24-hour ECG data recordings.
Timepoint [1] 0 0
Up to 2 weeks

Eligibility
Key inclusion criteria
All Subjects:



- 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.
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- 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.

Depressed Cohort Inclusion Criteria: Subject has current moderate or severe Major
Depressive Disorder Episode, based on DSM-IV criteria for diagnosis as documented by
clinician administered M.I.N.I plus HAMD-17 rating scale score =17.

Subject has presence of no or mild Major Depressive Disorder Episode,
based on DSM-IV criteria for diagnosis as documented by clinician administered M.I.N.I OR
HAMD-17 rating scale score <17.

Control Cohort Inclusion Criteria: Subject has no presence of mild, moderate, or severe
Major Depressive Disorder Episode, based on DSM-IV criteria for diagnosis as documented by
clinician administered M.I.N.I AND HAMD-17 rating scale score =7.

Subject has presence of mild, moderate, or severe Major Depressive
Disorder Episode, based on DSM-IV criteria for diagnosis as documented by clinician
administered M.I.N.I OR HAMD-17 rating scale score >7.

Study design
Purpose
Duration
Cross-sectional
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Epworth Clinic - Camberwell
Recruitment hospital [2] 0 0
The Melbourne Clinic - Richmond
Recruitment postcode(s) [1] 0 0
3124 - Camberwell
Recruitment postcode(s) [2] 0 0
3121 - Richmond
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Ohio
Country [3] 0 0
United States of America
State/province [3] 0 0
Oregon
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
United States of America
State/province [5] 0 0
Vermont

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Medibio Limited
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03529513
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Other publications