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New treatment option for Major Depressive Disorder (MDD)
Official title Evaluation of the Concordance Between Measures Obtained by a Medical Device for Emotional Monitoring (EMOCARE) and the Patient Health Questionnaire (PHQ-9) Score in Patients With Mild to Severe Depressive Episode
ClinicalTrials.gov ID: NCT06601140
What this study is testing
- What it's testing
- The aim of this clinical investigation is to find out whether the EMOCARE emotional monitoring software provides consistent results compared with the tools available for assessing the emotional state of patients suffering from mild to moderately severe depressive episod. It will also provide information on how patients feel about the use of passive monitoring software (without the active involvement of patient).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patient of both sexes aged 18 or over.
- Outpatient with unipolar depression (regardless of the time of the episode) (major depressive disorder).
- Patient with an episode of major depression supported by PHQ-9 score greater than or equal to 5.
- Patient with an episode of major depression supported by MADRS score greater than or equal to 7.
- Patient accustomed to regular use of a smartphone and/or computer
You likely can't join if
- Patient treated with antipsychotic drugs.
- Patient with an unstable pathology that could interfere with the study.
- Patient unable to communicate or cooperate with the investigator due to a low mental level, language difficulties or impaired cerebral function.
- Patient with an active suicidal tendency or patient who has had a suicidal episode in the last 6 months
- Patients with borderline personality disorders.
- Patient with a contra-indication to the product(s) under evaluation.
See the full eligibility criteria
- Patient of both sexes aged 18 or over.
- Outpatient with unipolar depression (regardless of the time of the episode) (major depressive disorder).
- Patient with an episode of major depression supported by PHQ-9 score greater than or equal to 5.
- Patient with an episode of major depression supported by MADRS score greater than or equal to 7.
- Patient accustomed to regular use of a smartphone and/or computer
- Patient who, in the opinion of the investigator, will comply with the requirements of the protocol.
- Patient affiliated to a social security scheme or beneficiary of such a scheme.
- Patient who has received full information about how the clinical investigation shall be conducted and has signed an informed consent form.
- Patient who reads and understands French.
- Patient who has undergone clinical screening adapted to the clinical investigation.
- Patient treated with antipsychotic drugs.
- Patient with an unstable pathology that could interfere with the study.
- Patient unable to communicate or cooperate with the investigator due to a low mental level, language difficulties or impaired cerebral function.
- Patient with an active suicidal tendency or patient who has had a suicidal episode in the last 6 months
- Patients with borderline personality disorders.
- Patient with a contra-indication to the product(s) under evaluation.
- Woman of childbearing age without effective contraception.
- Pregnant woman, birthing or breastfeeding mother
- Minor (not emancipated)
- Incapacitated person
The study team makes the final eligibility decision.
Where it's taking place
- Agen, France
- Caen, France
- Laxou, France
- Maxéville, France
- Nantes, France
- Paris, France
- Reims, France
- Rennes, France
- Saint-Grégoire, France
- Saint-Nazaire, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Agen, France; Caen, France; Laxou, France; Maxéville, France; Nantes, France; Paris, France and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.