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Identification of Physiological Data by a Wearable Monitor in Subjects Suffering From Major Depression Disorders

NCT05547035 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-03-05

No results posted yet for this study

Summary

To evaluate, over a period of six months, the links between physiological data collected such as electrodermal activity (or Galvanic Skin Response), motor activity measured by accelerometer, heartbeat measured by photoplestimograph and the clinical evaluation performed by the physician, in patients suffering from major depression disorder.

Conditions

Interventions

BEHAVIORAL

Patient follow-up of depression

All patients who agree to participate in the study are diagnosed by their GP/Psychiatrist with a diagnostic assessment instrument called DSM-5. Participants visit their GPs/Psychiatrists at baseline, month 1, month 2, month 3, month 4, month 5 and month 6. At each visit, the GPs/Psychiatrists: * assess the depression severity by using MADRS scale * assess the severity of illness at time of assessment compared with start of treatment by using CGI-S measures * the patient complete the self-administered questionnaire of HAD scale that measures the symptoms of anxiety and depression.

Sponsors & Collaborators

  • Digital For Mental Health

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-05
Primary Completion
2025-06-30
Completion
2025-06-30

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05547035 on ClinicalTrials.gov