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

NCT03538275 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2023-12-26

No results posted yet for this study

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

Interventions

OTHER

Monitoring test

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

Sponsors & Collaborators

  • Medibio Limited

    lead INDUSTRY

Principal Investigators

  • Melissa Bruner · Medibio Limited

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-13
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03538275 on ClinicalTrials.gov