Mood Disorder (Depressive Episodes)EC-102NCT07087353
Efficacy of Remote Monitoring in Patients Treated for Moderate to Severe Major Depressive Episodes
A study testing Edra PRO in people with Mood Disorder (Depressive Episodes), run by Resilience at 6 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mood Disorder (Depressive Episodes)
- What is being tested?
- Edra PRO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 594 participants
- Where
- 6 sitesFrance
- Study dates
- 31 Oct 2025to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Charles Ferté contact
6 sites in 1 country
France6 sites, 6 recruiting
- Recruiting
CHU Besançon
Besançon
Emmanuel Haffen
- Recruiting
CHU Grenoble Alpes
Grenoble
Mircea Polosan, Pr
- Recruiting
EPSM de VEndée
La Roche-sur-Yon
Anne Sauvaget, Dr
- Recruiting
CHU de Lille
Lille
Ali Amad, Pr
- Recruiting
Cabinet Corinne MARIE
Lisieux
Corinne MARIE, MD, +33632312570, corinne.marie0755@orange.fr
- Recruiting
CHU de Toulouse
Toulouse
Antoine Yrondi, Pr
About this study
Official title: A Randomized Controlled Trial Assessing the Efficacy of Remote Patient Monitoring in Patients Treated for a Moderate to Severe Major Depressive Episode
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.
Read the 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.
- Conditions
- Mood Disorder (Depressive Episodes)
- Being tested
- Edra PRO
- Medical subject headings
- Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Edra PRODevice
Remote monitoring software
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Edra PRO Receives: Device: Edra PRO |
| Control | No intervention | Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate over a 6-month period.
Difference in response rates (%) between the intervention group and the control group
Measured: Month 6
Secondary outcomes (3)
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
Measured: 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.
Measured: Month 6
Medico-economics impact of Edra PRO versus usual care
Analysis of cost of care
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start31 Oct 2025
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mood Disorder (Depressive Episodes)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 594 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Resilience
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Antoine Yrondi, MD, PhD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07087353
- Sponsor's protocol ID
- EC-102
- Other IDs
- 2025-A01782-47
- Acronym
- EC-102
- Status last verified
- Apr 2026
- First submitted
- 24 Jul 2025
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Assessing the Efficacy of Remote Patient Monitoring in Patients Treated for a Moderate to Severe Major Depressive Episode
- ClinicalTrials.gov ID
- NCT07087353
- Acronym / sponsor ID
- EC-102 / EC-102
- Conditions
- Mood Disorder (Depressive Episodes)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 594 participants (estimated)
- Lead sponsor
- ResilienceIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2025 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 28 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Edra PROEdra PRO |
| Control | No intervention | –Standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Edra PRORemote monitoring software | Device | Intervention |
Primary outcome
Response rate over a 6-month period.
Time frame: Month 6
Difference in response rates (%) between the intervention group and the control group
3 secondary outcomes
Safety and absence of defects in Edra PRO over a 6-month period
Time frame: Month 6
Impact of Edra PRO versus usual care on patients' quality of life
Time frame: Month 6
Medico-economics impact of Edra PRO versus usual care
Time frame: Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Charles Ferté contact
Antoine Yrondi, MD, PhD principal investigator
University Hospital, Toulouse
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Edra PRO in people with Mood Disorder (Depressive Episodes), run by Resilience at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emma Touré Cuq, PharmD (+33646396617, emma.tourecuq@resilience.care), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate over a 6-month period. (time frame: Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.