Mood Disorder (Depressive Episodes)
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEEdra PRO
Remote monitoring software
Sponsors
Resilience
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 guardianship or conservatorship * Ongoing alcohol or drug abuse considered likely to interfere with study participation, as judged by the investigator * Psychiatric or physical comorbidities (e.g., severe neurological or cardiovascular conditions) considered likely to interfere with participation or study results, at the discretion of the Principal Investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response rate over a 6-month period. | Month 6 | Difference in response rates (%) between the intervention group and the control group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and absence of defects in Edra PRO over a 6-month period | Month 6 | Analysis of adverse events in both arms and reported device deficiencies in the intervention group |
| Impact of Edra PRO versus usual care on patients' quality of life | Month 6 | Short Form-36 questionnaire. Ranges from 0 to 100, with higher scores indicating better health-related quality of life. |
| Medico-economics impact of Edra PRO versus usual care | Month 6 | Analysis of cost of care |
Countries
France
Contacts
CONTACTEmma Touré Cuq, PharmD
CONTACTCharles Ferté
PRINCIPAL_INVESTIGATORAntoine Yrondi, MD, PhD
University Hospital, Toulouse
Outcome results
None listed