Efficacy of Remote Monitoring in Patients Treated for Moderate to Severe Major Depressive Episodes
Recruiting
N/A
Interventional Study
Mood Disorder (Depressive Episodes)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 594 (estimated)
- Sponsor
- Resilience · Industry
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About This Trial
Mood disorders like depression and bipolar disorder are widespread and cause serious psychological, cognitive, and social impairments, with a high burden on healthcare systems. Edra PRO is a digital medical device developed to support clinical decision-making and remotely monitor symptoms in psychiatric patients. The EC-102 randomized controlled trial will evaluate its impact compared to usual car…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Adults (≥18 years old) meeting ICD-11 criteria for a moderate to severe major depressive episode
* Access to a personal smartphone and an internet connection, and cognitively able to use it independently
Exclusion Criteria:
* Pregnant women
* Individuals under legal guardian…
Contacts