Identification of Physiological Data by a Wearable Monitor in Subjects Suffering From Major Depre… (NCT05547035) | Clinical Trial Compass
UnknownNot Applicable
Identification of Physiological Data by a Wearable Monitor in Subjects Suffering From Major Depression Disorders
France200 participantsStarted 2017-09-05
Plain-language summary
To evaluate, over a period of six months, the links between physiological data collected such as electrodermal activity (or Galvanic Skin Response), motor activity measured by accelerometer, heartbeat measured by photoplestimograph and the clinical evaluation performed by the physician, in patients suffering from major depression disorder.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient able to give written informed consent, - Presenting a major depressive episode defined according to DSM V criteria, - Presenting a MADRS score ≥ 20 - Able to understand all study procedures and follow-up
Exclusion Criteria:
* \- Inability to wear the wearable monitor for the duration of the study (6 months)
* Patient with a severe medical condition at the discretion of the investigator (neurological, rheumatological, etc.)
* Resistant depression
* Chronic depression, dysthymia
* Depression with psychotic features not congruent with mood, schizophrenia disorder
* Depression with catatonic features
* Substance use disorder in the last 6 months
* Extreme sports during the conduct of the study
* Pre-existing skin infection at the wearable monitor site
* Pregnant or lactating woman
* Participation in another drug or medical device study
* Inability to give informed consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Comparison of change in MADRS ( Montgomery-Asberg Depression Rating Scale) total score with physiological measurements.