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Medibio DDA Confirmatory Performance Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03529513
Recruitment Status : Completed
First Posted : May 18, 2018
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
Medibio Limited

Tracking Information
First Submitted Date January 29, 2018
First Posted Date May 18, 2018
Last Update Posted Date May 18, 2018
Actual Study Start Date August 18, 2017
Actual Primary Completion Date May 4, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 7, 2018)
Measure heart rate variability [ Time Frame: Up to 2 weeks ]
The Medibio Algorithm will process data from subject 24-hour ECG data recordings.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Medibio DDA Confirmatory Performance Study
Official Title Medibio Depression Diagnostic Aid Confirmatory Performance Study
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Major Depressive Episode
Intervention
  • 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.
    Other Name: M.I.N.I.
  • 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.
    Other Name: HAMD-17
Study Groups/Cohorts
  • 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.
    Interventions:
    • 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.
    Interventions:
    • Diagnostic Test: Medibio Depression Diagnostic Aid
    • Diagnostic Test: Mini International Neuropsychiatric Interview
    • Diagnostic Test: Hamilton Rating Scale for Depression - 17 Item
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 7, 2018)
234
Original Actual Enrollment Same as current
Actual Study Completion Date May 4, 2018
Actual Primary Completion Date May 4, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

All Subjects:

Inclusion Criteria:

  • 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.

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.

Exclusion Criteria: 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.

Exclusion Criteria: 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.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Australia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03529513
Other Study ID Numbers MB-DEPDX04
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: IPD will not be shared with other researchers.
Responsible Party Medibio Limited
Study Sponsor Medibio Limited
Collaborators Not Provided
Investigators Not Provided
PRS Account Medibio Limited
Verification Date May 2018