Remote monitoring for adults with depression using ThIA Suivi

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional phase 1 trial evaluates ThIA Suivi, a digital remote-monitoring device, in adults with diagnosed depression. Participants continue their regular psychiatric care while either using the ThIA Suivi tool or receiving usual care. The primary outcome is the share of patients with a clinically meaningful improvement in depression symptoms, defined as a 5-point or greater reduction on the PHQ-9 after 3 months. Questionnaires track symptom changes over time, and safety and adherence are monitored. The study is conducted under real-world clinical supervision at multiple French centers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients with a PHQ-9 score of ≥ 15 and a confirmed diagnosis of depression
* Patients under the care of the investigator;
* Patients who have not received any treatment for at least 6 weeks and to whom the investigator prescribes an antidepressant.
* Patients with a smartphone, computer or tablet with internet access;
* Patients covered by a health insurance scheme;
* Patients able to read and understand French;
* Patients who have signed a written, informed consent form in person to take part in the study.

Exclusion Criteria:

* Patients under guardianship, curatorship or judicial protection, or subject to any other administrative or judicial measure resulting in the deprivation of rights and freedoms;
* Patients with neurocognitive disorders or psychiatric conditions (e.g. psychotic disorders, cognitive impairments or manic states) that may compromise their ability to give free and informed consent and/or to comply with the study protocol;
* Patients at imminent risk of suicide or with severe depression accompanied by psychotic symptoms;
* Patients deemed non-autonomous by the psychiatrist, i.e. those who, according to clinical assessment, are unable to manage their daily activities independently or lack sound judgement;
* Patients already enrolled in another interventional study
* Vulnerable persons as defined in Articles L. 1121-5 to 8 and L. 1122-1-2 of the French Public Health Code are excluded from the study.

Where it's running

• Centre Hospitalier Le Vinatier
  Bron, France Recruiting
• Hôpital Novo
  Pontoise, France Recruiting
• Hôpital Uzès - Le Mas Careiron Secteur 30G07 - CMP de Saint Hippolyte du Fort
  Uzès, France Recruiting

Study contacts

• Study coordinator: Nicolas Desrumaux, PhD
• Email: admin@digitalmedicalhub.com
• Phone: 0033684979459

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.