Ignite Creation Date:
2024-05-06 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 12:46 PM
Study NCT ID:
NCT03538275
Status:
COMPLETED
Last Update Posted:
2023-12-26
First Post:
2018-05-03
Brief Title:
Chronobiology and Depression Circadian Analytics as a Biomarker for Depressive Subtypes
Sponsor:
Medibio Limited
Organization:
Medibio Limited
Study Overview
Official Title:
Chronobiology and Depression Circadian Analytics as a Biomarker for Diagnosis and Longitudinal Monitoring of Depressive Subtypes
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 sponsorinvestigator 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 t0 at t4 weeks and at t8 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
Phase I will serve as a non-blinded discovery phase for Medibio algorithm development
Phase II is optional based upon sponsorinvestigator 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 t0 at t4 weeks and at t8 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None