Major Depressive Disorder (MDD)
Conditions
Brief summary
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). The main questions it aims to answer are as follows: Does EMOCARE provide consistent results compared with tools already used in current practice? What are the medical problems encountered by participants when using EMOCARE? The researchers will compare EMCOCARE to various questionnaires usually used in the management of patients suffering from depression (PHQ-9, MADRS, GAD-7, BDI-II, EQ-5D-5L). Participants who agree to take part in the study, during a selection visit, will be able to: 1. Install the software on a digital interface (smartphone, computer, etc.) and activate or deactivate it whenever they wish during the 6-week follow-up period. 2. Attend 2 scheduled appointments at the centre (a first appointment then a second 6 weeks later) to complete a series of questionnaires, being questioned by the doctor, and fill in other questionnaires on their own. 3. At home, answer questionnaires independently, 2 weeks and 4 weeks after the first appointment. 4. Receive a telephone call from the doctor 3 weeks after the first appointment to find out how the participants are feeling. 5. Keep a diary with the symptoms they have experienced, any medical consultations they have made, or changes in drug treatment.
Interventions
DEVICEEMOCARE software
Use of the EMOCARE software on the digital device of participant (smartphone, computer, etc.). The participant can activate and deactivate the software whenever he wishes.
Sponsors
Emobot
Nantes University Hospital
Private psychiatric practice, Saint-Nazaire
Groupement Hospitalier Paul Guiraud, Villejuif
Centre Hospitalier Guillaume Régnier, RENNES
Centre de Psychothérapie Nancéen, Laxou
Rumb
Private psychiatric pratice, Agen
Private psychiatric pratice, Caen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Masking description
Patient health questionnaire - 9 (PHQ-9) and (Montgomery Asberg Depression Rating Scale) MADRS assessments will be performed by an investigator who doesn't know the score obtained with EMOCARE
Intervention model description
The participant will continuously use the EMOCARE software during the 6 weeks of follow-up and will answer the questionnaires usually used on a regular basis over the same period.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of scores EMOCARE | From baseline to 6 weeks | Absolute difference |
| Change of scores PHQ-9 self-administrered | From baseline to 6 weeks | Absolute difference |
Secondary
| Measure | Time frame |
|---|---|
| Score EMOCARE | At baseline, at 2 weeks, at 4 weeks |
| Change of EMOCARE score | From baseline to 2 weeks, from baseline to 4 weeks |
| Score PHQ-9 self administered | At baseline, at 2 weeks, at 4 weeks, at 6 weeks |
| Change of score PHQ-9 self administered | From baseline to 2 weeks, From baseline to 4 weeks |
| Score PHQ-9 administered by an investigator | At baseline, at 6 weeks |
| Change of score PHQ-9 administered by an investigator | From baseline to 6 weeks |
| Score MADRS administered by an investigator | At baseline, at 6 weeks |
| Change of MADRS administered by an investigator | From baseline to 6 weeks |
| Score BDI-II | At baseline, at 6 weeks |
| Change of BDI-II | From baseline to 6 weeks |
| EMOCARE operating time | From baseline to 2 weeks, from baseline to 4 weeks, from baseline to 6 weeks |
| EQ-5D-5L | At baseline, at 6 weeks |
| Number of patient with adverse event | At baseline, at 2 weeks, at 3 weeks, at 4 weeks, at 6 weeks |
| Acceptability of medical device questionnaire | At baseline, at 6 weeks |
Countries
France
Contacts
CONTACTTanel PETELOT
Outcome results
None listed