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Efficacy of Remote Monitoring in Patients Treated for Moderate to Major Depressive Episodes

NCT ID: NCT07087353

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

594 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-31

Study Completion Date

2027-12-01

Brief Summary

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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

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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

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Mood Disorder (Depressive Episodes)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention

Edra PRO

Group Type EXPERIMENTAL

Edra PRO

Intervention Type DEVICE

Remote monitoring software

Control

Standard care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Edra PRO

Remote monitoring software

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Resilience

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Antoine Yrondi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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Cabinet Corinne MARIE

Lisieux, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Emma Touré Cuq, PharmD

Role: CONTACT

[email protected]
+33646396617

Charles Ferté

Role: CONTACT

[email protected]

Facility Contacts

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Corinne MARIE, MD

Role: primary

[email protected]
+33632312570

Other Identifiers

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2025-A01151-48

Identifier Type: OTHER

Identifier Source: secondary_id

EC-102

Identifier Type: -

Identifier Source: org_study_id