Chronobiology and Depression: Circadian Analytics as a Biomarker for Depressive Subtypes

NCT03538275 | Completed

• 1 other identifier: MB-DEPMON01
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression, Bipolar; Depression, Unipolar; Healthy

Outcome Measures

Primary Outcomes (1)

• Medibio platform classification

  The Medibio platform will use 24 hours recording to monitor disease severity

  Through study completion, an average of 8 weeks

Study Arms (3)

Unipolar depression cohort

Subjects with a known Dx of unipolar depression.

Other: Monitoring test

Bipolar depression cohort

Subjects with a known Dx of bipolar disorder

Other: Monitoring test

Healthy Control cohort

Subjects with no known unipolar or bipolar Dx.

Other: Monitoring test

Interventions

Monitoring test OTHER

Participants wear Zephyr BioPatch for three 24-hour periods and ZMachine Insight for three sleep periods.

Bipolar depression cohort; Healthy Control cohort; Unipolar depression cohort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Medibio Limited: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Bipolar Disorder; Depressive Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• Melissa Bruner

  Medibio Limited

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2018
• First Posted: May 29, 2018
• Study Start: March 13, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: December 26, 2023

Record last verified: 2023-12

Locations

US (1)