Major Depressive EpisodeNCT03529513
Medibio DDA Confirmatory Performance Study
An observational study of Major Depressive Episode, run by Medibio Limited at 8 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Episode
- What is being tested?
- Medibio Depression Diagnostic Aid, Mini International Neuropsychiatric Interview and Hamilton Rating Scale for Depression - 17 Item
- Type of treatment
- Injection or infusion
- How many people
- 234 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 18 Aug 2017to 4 May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects who may be currently experiencing an episode of depression that are being diagnosed or treated in a mental health setting.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States6 sites
FutureSearch Trials
Dallas, Texas, 75231
CNS Network
Garden Grove, California, 92845
Lindner Center of HOPE
Mason, Ohio, 45040
OCCI, Inc.
Salem, Oregon, 97301
CNS Network
Torrance, California, 90502
White River Junction Veterans Affairs Medical Center
White River Junction, Vermont, 05009
Australia2 sites
Epworth Clinic
Camberwell, Victoria, 3124
The Melbourne Clinic
Richmond, Victoria, 3121
About this study
Official title: Medibio Depression Diagnostic Aid Confirmatory Performance Study
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.
Read the 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.
- Conditions
- Major Depressive Episode
- Being tested
- Medibio Depression Diagnostic Aid, Mini International Neuropsychiatric Interview, Hamilton Rating Scale for Depression - 17 Item
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medibio Depression Diagnostic AidDiagnostic test
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 InterviewDiagnostic test
Also called M.I.N.I.
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 ItemDiagnostic test
Also called HAMD-17
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Medibio Depression Diagnostic Aid; Diagnostic Test: Mini International Neuropsychiatric Interview; Diagnostic Test: Hamilton Rating Scale for Depression - 17 Item |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure heart rate variability
The Medibio Algorithm will process data from subject 24-hour ECG data recordings.
Measured: Up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2018
- Study start18 Aug 2017
- Primary completion4 May 2018
- Study completion4 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive EpisodeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medibio Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Melissa Bruner, Study director, Medibio Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03529513
- Sponsor's protocol ID
- MB-DEPDX04
- Status last verified
- Dec 2023
- First submitted
- 29 Jan 2018
- Last updated
- 21 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: IPD will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medibio Depression Diagnostic Aid Confirmatory Performance Study
- ClinicalTrials.gov ID
- NCT03529513
- Acronym / sponsor ID
- MB-DEPDX04
- Conditions
- Major Depressive Episode
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Medibio LimitedIndustry (pharma, biotech, devices)
- Study start
- 18 Aug 2017 (actual)
- Primary completion
- 4 May 2018 (actual)
- Study completion
- 4 May 2018 (actual)
- First posted
- 18 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Depressed | – | Diagnostic Test: Medibio Depression Diagnostic Aid, Diagnostic Test: Mini International Neuropsychiatric Interview, Diagnostic Test: Hamilton Rating Scale for Depression - 17 ItemSubjects 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 | – | Diagnostic Test: Medibio Depression Diagnostic Aid, Diagnostic Test: Mini International Neuropsychiatric Interview, Diagnostic Test: Hamilton Rating Scale for Depression - 17 ItemSubjects 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who may be currently experiencing an episode of depression that are being diagnosed or treated in a mental health setting.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medibio Depression Diagnostic AidThe 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 | Control, Depressed |
| Mini International Neuropsychiatric InterviewAlso: M.I.N.I.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 | Control, Depressed |
| Hamilton Rating Scale for Depression - 17 ItemAlso: HAMD-17The 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. | Diagnostic test | Control, Depressed |
Primary outcome
Measure heart rate variability
Time frame: Up to 2 weeks
The Medibio Algorithm will process data from subject 24-hour ECG data recordings.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa Bruner study director
Medibio Limited
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Episode, run by Medibio Limited at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure heart rate variability (time frame: Up to 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2023.