RecruitingNot ApplicableNCT05547035

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

Prospective, Multicenter Non-randomised, Open-label Study Evaluating the Correlation Between Physiological Data Measured by a Portable Sensor and Psychometric Assessment


Sponsor

Digital For Mental Health

Enrollment

200 participants

Start Date

Sep 5, 2017

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a wearable monitor (like a smartwatch or biosensor) can detect and track physical signals (such as heart rate, sleep, or movement patterns) that reflect how someone with major depression is feeling. The goal is to improve monitoring of depression between doctor visits. **You may be eligible if...** - You have been diagnosed with a major depressive episode (under DSM-5 criteria) - Your depression score on a standard scale (MADRS) is 20 or higher, indicating moderate-to-severe symptoms - You are willing and able to wear the device for 6 months - You can understand and follow the study procedures **You may NOT be eligible if...** - You have treatment-resistant or chronic depression - You have depression with psychotic features, schizophrenia, or bipolar disorder - You have a substance use disorder in the last 6 months - You have a severe physical condition that would affect wearing the device - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALPatient 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.


Locations(11)

135 rue Nestor Longue Epee

Bersée, France

203 rue de la Motte

Bersée, France

APPT 22 Residence les Tilleuls

Dax, France

2 boulevard Winston Churchill

Dijon, France

2 boulevard Winston Churchill

Dijon, France

Clinique Lyon Lumiere

Meyzieu, France

22 rue Jacques Boutrolles

Mont-Saint-Aignan, France

19 rue de la Liberté

Nice, France

145 avenue des Minimes

Toulouse, France

119 rue de la Pompe

Paris, France

91 rue Caulaincpurt

Paris, France

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NCT05547035


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