An interventional study of Edra PRO in Mood Disorder (Depressive Episodes), sponsored by Resilience. Recruiting at 6 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-01.
Sponsored by Resilience · Not applicable, Interventional, and Treatment
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 care on symptoms, quality of life, healthcare costs, comorbidities, and user adherence and satisfaction.
Mood disorders such as depression and bipolar disorder affect a large portion of the global population and cause significant psychological, cognitive, and functional impairments, along with high healthcare costs. Despite available treatments, sustained remission is hard to achieve, and many patients experience persistent symptoms and treatment side effects. Continuous remote monitoring could improve care and outcomes. Edra PRO is a digital medical device designed for remote symptom tracking and clinical decision support in psychiatry. The EC-102 randomized controlled trial will assess the impact of Edra PRO versus usual care on symptoms, quality of life, healthcare costs, comorbidities, and user satisfaction and adherence.
561 studies on the registry are indexed under Mood Disorders; 105 are open to participants now.
This study's planned enrollment of 594 is above the median of 80 across 419 interventional studies indexed under Mood Disorders.
Browse Mood Disorders studies →Resilience is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Edra PRO
Device: Edra PRO
Standard care
Remote monitoring software
Response rate over a 6-month period.
Difference in response rates (%) between the intervention group and the control group
Time frame: Month 6
Safety and absence of defects in Edra PRO over a 6-month period
Analysis of adverse events in both arms and reported device deficiencies in the intervention group
Time frame: Month 6
Impact of Edra PRO versus usual care on patients' quality of life
Short Form-36 questionnaire. Ranges from 0 to 100, with higher scores indicating better health-related quality of life.
Time frame: Month 6
Medico-economics impact of Edra PRO versus usual care
Analysis of cost of care
Time frame: Month 6
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Resilience