Informations générales (source: ClinicalTrials.gov)
Prospective, Multicenter Non-randomised, Open-label Study Evaluating the Correlation Between Physiological Data Measured by a Portable Sensor and Psychometric Assessment (MYND104)
Interventional
N/A
Digital For Mental Health (Voir sur ClinicalTrials)
septembre 2017
juin 2025
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| SAFT RUE DE PARIS ETAMPES | Geneviève Saint-Mard, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| 135 rue Nestor Longue Epee - 59235 - Bersée - France | Laurie Vuylsteker, MD | Contact (sur clinicalTrials) | |||
| 145 avenue des Minimes - 31200 - Toulouse - France | David Modavi, MD | Contact (sur clinicalTrials) | |||
| 19 rue de la Liberté - 06000 - Nice - France | Muriel Sasia, MD | Contact (sur clinicalTrials) | |||
| 2 boulevard Winston Churchill - 21000 - Dijon - France | Christophe Boisselier, MD | Contact (sur clinicalTrials) | |||
| 2 boulevard Winston Churchill - 21000. - Dijon - France | François Arcos, MD | Contact (sur clinicalTrials) | |||
| 203 rue de la Motte - 59235 - Bersée - France | Delsart Dominique, MD | Contact (sur clinicalTrials) | |||
| 22 rue Jacques Boutrolles - 76130 - Mont-Saint-Aignan - France | Marc Martin, MD | Contact (sur clinicalTrials) | |||
| 91 rue Caulaincpurt - 75018 - Paris - France | Véronique Marais-Morini, MD | Contact (sur clinicalTrials) | |||
| APPT 22 Residence les Tilleuls - 40100 - Dax - France | Carbonniere Patrick, MD | Contact (sur clinicalTrials) | |||
| Clinique Lyon Lumiere - 69330 - Meyzieu - France | Alexandre Thoinet, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
-
- 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