Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
234 participants
OBSERVATIONAL
2017-08-18
2018-05-04
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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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.
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.
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.
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.
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.
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.
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.
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.
Interventions
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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.
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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject has ability to read and understand the instructions for the study.
* Subject is willing to adhere to study procedures.
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
Yes
Sponsors
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Medibio Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Melissa Bruner
Role: STUDY_DIRECTOR
Medibio Limited
Locations
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CNS Network
Garden Grove, California, United States
CNS Network
Torrance, California, United States
Lindner Center of HOPE
Mason, Ohio, United States
OCCI, Inc.
Salem, Oregon, United States
FutureSearch Trials
Dallas, Texas, United States
White River Junction Veterans Affairs Medical Center
White River Junction, Vermont, United States
Epworth Clinic
Camberwell, Victoria, Australia
The Melbourne Clinic
Richmond, Victoria, Australia
Countries
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Other Identifiers
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MB-DEPDX04
Identifier Type: -
Identifier Source: org_study_id