Depression, BipolarNCT03538275
Chronobiology and Depression: Circadian Analytics as a Biomarker for Depressive Subtypes
An observational study of Depression, Bipolar and Depression, Unipolar, run by Medibio Limited at 1 site in United States.
Trial summary
An objective measure of treatment response could be a valuable new tool in the armamentarium of depression management, and this holds true for stimulation-based and pharmacological therapies alike. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Bipolar, Depression, Unipolar, Healthy
- What is being tested?
- Monitoring test
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2018to 31 Dec 2019
- 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 will be enrolled at 1 site in the United States. Depressed subjects (bipolar and unipolar sub-types) will be recruited from outpatient clinics via direct physician referral and flyers. The study should be conducted with adequate representation of men and women; a minimum enrollment of 25% male subjects is desired. There are no enrollment restrictions based upon race or ethnic origin.
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 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.
- Subject has bipolar disorder.
- Subject has active psychotic symptoms.
- 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 has a STOP-BANG score of ≥5 OR has a Home Sleep Test assessment (ApneaLink, ResMed) demonstrating AHI≥15.
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- Subject has a pacemaker.
- Subject currently uses benzodiazepines, sedative-hypnotics, or trazadone on a scheduled basis OR will be likely be prescribed such medication during the 8-week observational phase of the study.
- Subject currently uses antipsychotic medication for any indication OR will be likely be prescribed such medication during the 8-week observational phase of the study.
- Subject currently uses chronotropic medication, such as beta-blockers, digoxin, sinoatrial/atrioventricular nodal-acting calcium channel blockers, and 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, or participated in a clinical study in the past 30 days during which an investigational device or drug was used.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chronobiology and Depression: Circadian Analytics as a Biomarker for Diagnosis and Longitudinal Monitoring of Depressive Subtypes
An objective measure of treatment response could be a valuable new tool in the armamentarium of depression management, and this holds true for stimulation-based and pharmacological therapies alike. Hence, the Medibio Depression Monitoring Study will use the Medibio analytics platform to characterize autonomic, circadian, and sleep patterns before and during the initial 8 weeks of pharmacologic therapy for moderate-to-severe depression. The study will also explore any differences in these measures between treatment responders and non-responders, and between depression subtypes, including bipolar and unipolar depression. The study will also characterize longitudinal, ambulatory EEG measures throughout the observation period.
Read the detailed description
This longitudinal, two-phase, three-arm, exploratory, observational study will use the Medibio analytics platform-with heart rate, activity, postural, and EEG data inputs-to characterize autonomic, circadian, and sleep patterns in unipolar depressed and bipolar depressed patients, which will include those with atypical and melancholic subtypes, undergoing the initial phase of standard pharmacological treatment, as well as in a non-depressed control group.
Phase I will serve as a non-blinded, discovery phase for Medibio algorithm development.
Phase II is optional, based upon sponsor/investigator assessment of results from Phase I. Phase II procedures will be identical to those in Phase I, with the exception that the Medibio algorithm will be blinded to clinical classification and status.
The study cohorts will comprise: a) individuals initiating standard pharmacologic therapy with SSRIs for moderate-to- severe unipolar depression (will include subjects with melancholic and atypical subtypes), b) individuals initiating standard pharmacologic therapy with lamotrigine, lithium, or valproate for moderate or severe bipolar I or II depression (will also include subjects with melancholic and atypical subtypes), and c) non-depressed individuals who have been matched at the group level for age and gender (control subjects). Before the commencement of pharmacologic therapy (Baseline, t=0), at t=4 weeks, and at t=8 weeks, heart rate, activity, postural data will be collected using the Zephyr BioPatch (Medtronic, Inc.) and ambulatory EEG data will be collected using the ZMachine Insight (General Sleep Corp). Recordings at each time point will consist of three 24-hour Zephyr recordings and three overnight ZMachine recordings.
Clinical assessments will also be captured at the same time points, comprising both clinician-administered instruments [Clinical Global Impression (CGI), Hamilton Depression Rating Scale-17 (HAMD-17), and Young Mania Rating Scale (YMRS)] and subject self-rated instruments [Patient Health Questionnaire-9 (PHQ-9) and Quick Inventory of Depressive Symptomatology-Self Report (QIDS SR16)]. Zephyr and ZMachine data will be filtered based on quality (duration and completeness) and may be 'de-noised,' then will be processed by the Medibio platform to generate autonomic, circadian, and sleep metrics for use in the statistical analysis of study results.
- Conditions
- Depression, Bipolar, Depression, Unipolar, Healthy
- Being tested
- Monitoring test
- Medical subject headings
- Bipolar Disorder, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring testOther
Participants wear Zephyr BioPatch for three 24-hour periods and ZMachine Insight for three sleep periods.
| Study group | Role | What they receive |
|---|---|---|
| Unipolar depression cohort | Subjects with a known Dx of unipolar depression. Receives: Other: Monitoring test | |
| Bipolar depression cohort | Subjects with a known Dx of bipolar disorder Receives: Other: Monitoring test | |
| Healthy Control cohort | Subjects with no known unipolar or bipolar Dx. Receives: Other: Monitoring test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medibio platform classification
The Medibio platform will use 24 hours recording to monitor disease severity
Measured: Through study completion, an average of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start13 Mar 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, BipolarStudies 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
- Prospective
- Enrolment
- 80 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
- NCT03538275
- Sponsor's protocol ID
- MB-DEPMON01
- Status last verified
- Dec 2023
- First submitted
- 3 May 2018
- Last updated
- 26 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronobiology and Depression: Circadian Analytics as a Biomarker for Diagnosis and Longitudinal Monitoring of Depressive Subtypes
- ClinicalTrials.gov ID
- NCT03538275
- Acronym / sponsor ID
- MB-DEPMON01
- Conditions
- Depression, Bipolar, Depression, Unipolar, Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Medibio LimitedIndustry (pharma, biotech, devices)
- Study start
- 13 Mar 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 29 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.
An objective measure of treatment response could be a valuable new tool in the armamentarium of depression management, and this holds true for stimulation-based and pharmacological therapies alike. Hence, the Medibio Depression Monitoring Study will use the Medibio analytics platform to characterize autonomic, circadian, and sleep patterns before and during the initial 8 weeks of pharmacologic therapy for moderate-to-severe depression. The study will also explore any differences in these measures between treatment responders and non-responders, and between depression subtypes, including bipolar and unipolar depression. The study will also characterize longitudinal, ambulatory EEG measures throughout the observation period.
Detailed description
This longitudinal, two-phase, three-arm, exploratory, observational study will use the Medibio analytics platform-with heart rate, activity, postural, and EEG data inputs-to characterize autonomic, circadian, and sleep patterns in unipolar depressed and bipolar depressed patients, which will include those with atypical and melancholic subtypes, undergoing the initial phase of standard pharmacological treatment, as well as in a non-depressed control group.
Phase I will serve as a non-blinded, discovery phase for Medibio algorithm development.
Phase II is optional, based upon sponsor/investigator assessment of results from Phase I. Phase II procedures will be identical to those in Phase I, with the exception that the Medibio algorithm will be blinded to clinical classification and status.
The study cohorts will comprise: a) individuals initiating standard pharmacologic therapy with SSRIs for moderate-to- severe unipolar depression (will include subjects with melancholic and atypical subtypes), b) individuals initiating standard pharmacologic therapy with lamotrigine, lithium, or valproate for moderate or severe bipolar I or II depression (will also include subjects with melancholic and atypical subtypes), and c) non-depressed individuals who have been matched at the group level for age and gender (control subjects). Before the commencement of pharmacologic therapy (Baseline, t=0), at t=4 weeks, and at t=8 weeks, heart rate, activity, postural data will be collected using the Zephyr BioPatch (Medtronic, Inc.) and ambulatory EEG data will be collected using the ZMachine Insight (General Sleep Corp). Recordings at each time point will consist of three 24-hour Zephyr recordings and three overnight ZMachine recordings.
Clinical assessments will also be captured at the same time points, comprising both clinician-administered instruments [Clinical Global Impression (CGI), Hamilton Depression Rating Scale-17 (HAMD-17), and Young Mania Rating Scale (YMRS)] and subject self-rated instruments [Patient Health Questionnaire-9 (PHQ-9) and Quick Inventory of Depressive Symptomatology-Self Report (QIDS SR16)]. Zephyr and ZMachine data will be filtered based on quality (duration and completeness) and may be 'de-noised,' then will be processed by the Medibio platform to generate autonomic, circadian, and sleep metrics for use in the statistical analysis of study results.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Unipolar depression cohort | – | Other: Monitoring testSubjects with a known Dx of unipolar depression. |
| Bipolar depression cohort | – | Other: Monitoring testSubjects with a known Dx of bipolar disorder |
| Healthy Control cohort | – | Other: Monitoring testSubjects with no known unipolar or bipolar Dx. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be enrolled at 1 site in the United States. Depressed subjects (bipolar and unipolar sub-types) will be recruited from outpatient clinics via direct physician referral and flyers. The study should be conducted with adequate representation of men and women; a minimum enrollment of 25% male subjects is desired. There are no enrollment restrictions based upon race or ethnic origin.
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 (15 listed)
- 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.
- Subject has bipolar disorder.
- Subject has active psychotic symptoms.
- 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.
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 |
|---|---|---|
| Monitoring testParticipants wear Zephyr BioPatch for three 24-hour periods and ZMachine Insight for three sleep periods. | Other | Bipolar depression cohort, Healthy Control cohort, Unipolar depression cohort |
Primary outcome
Medibio platform classification
Time frame: Through study completion, an average of 8 weeks
The Medibio platform will use 24 hours recording to monitor disease severity
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 26 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, Bipolar and Depression, Unipolar, run by Medibio Limited at 1 site in United States.
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 15 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 26 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 1 site in United States. 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?
Medibio platform classification (time frame: Through study completion, an average of 8 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 26 Dec 2023.