Medibio DDA Confirmatory Performance Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Medibio Depression Diagnostic Aid Confirmatory Performance Study

Conditions
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Major Depressive Episode

Intervention / Treatment
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* Diagnostic Test: Medibio Depression Diagnostic Aid
* Diagnostic Test: Mini International Neuropsychiatric Interview
* Diagnostic Test: Hamilton Rating Scale for Depression - 17 Item


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Depressed<br>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<br>* 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.<br>Diagnostic Test: Mini International Neuropsychiatric Interview<br>* 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.<br>* Other names: M.I.N.I.;Diagnostic Test: Hamilton Rating Scale for Depression - 17 Item<br>* 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.<br>* Other names: HAMD-17;|
| Control<br>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<br>* 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.<br>Diagnostic Test: Mini International Neuropsychiatric Interview<br>* 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.<br>* Other names: M.I.N.I.;Diagnostic Test: Hamilton Rating Scale for Depression - 17 Item<br>* 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.<br>* Other names: HAMD-17;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure heart rate variability | The Medibio Algorithm will process data from subject 24-hour ECG data recordings. | Up to 2 weeks |