[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Emobot\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":64},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100562282","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-100562282",false,"NCT06601140","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","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: Prospective, Multicentric, Comparative, Single Blind Clinical Investigation. EMC1 Study","EMC1","Inclusion Criteria:\n\n* Patient of both sexes aged 18 or over.\n* Outpatient with unipolar depression (regardless of the time of the episode) (major depressive disorder).\n* Patient with an episode of major depression supported by PHQ-9 score greater than or equal to 5.\n* Patient with an episode of major depression supported by MADRS score greater than or equal to 7.\n* Patient accustomed to regular use of a smartphone and\u002For computer\n* Patient who, in the opinion of the investigator, will comply with the requirements of the protocol.\n* Patient affiliated to a social security scheme or beneficiary of such a scheme.\n* Patient who has received full information about how the clinical investigation shall be conducted and has signed an informed consent form.\n* Patient who reads and understands French.\n* Patient who has undergone clinical screening adapted to the clinical investigation.\n\nExclusion Criteria:\n\n* Patient treated with antipsychotic drugs.\n* Patient with an unstable pathology that could interfere with the study.\n* Patient unable to communicate or cooperate with the investigator due to a low mental level, language difficulties or impaired cerebral function.\n* Patient with an active suicidal tendency or patient who has had a suicidal episode in the last 6 months\n* Patients with borderline personality disorders.\n* Patient with a contra-indication to the product(s) under evaluation.\n* Woman of childbearing age without effective contraception.\n* Pregnant woman, birthing or breastfeeding mother\n* Minor (not emancipated)\n* Incapacitated person","ALL","18 Years",{"count":20,"type":21},104,"ESTIMATED","INTERVENTIONAL",[24],"NA","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:\n\nDoes EMOCARE provide consistent results compared with tools already used in current practice? What are the medical problems encountered by participants when using EMOCARE?\n\nThe 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).\n\nParticipants who agree to take part in the study, during a selection visit, will be able to:\n\n1. 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.\n2. 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.\n3. At home, answer questionnaires independently, 2 weeks and 4 weeks after the first appointment.\n4. Receive a telephone call from the doctor 3 weeks after the first appointment to find out how the participants are feeling.\n5. Keep a diary with the symptoms they have experienced, any medical consultations they have made, or changes in drug treatment.",[27],"Major Depressive Disorder (MDD)","RECRUITING","2026-02-18",{"date":31,"type":32},"2026-02-19","ACTUAL",{"date":34,"type":32},"2025-03-05",{"date":36,"type":21},"2027-02-04",{"name":38,"class":39},"Emobot","INDUSTRY",11,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":5},"100582196","validation-of-emodtx-as-a-digital-endpoint-for-mood-monitoring-in-adult-patients-suffering-from-unipolar-depression-100582196","NCT06860165","Validation of EmoDTx as a Digital Endpoint for Mood Monitoring in Adult Patients Suffering From Unipolar Depression","Validation of EmoDTx as a Digital Endpoint for Mood Monitoring in Adult Patients With Unipolar Depression: An Observational Study Against Standard Depression Assessment Questionnaires","EMC2FR","Inclusion criteria:\n\n1. Outpatients diagnosed with mild to severe unipolar disorder\n2. Age ≥ 18 years old\n3. Patients willing and able to participate (i.e willing to use the EmoDTx App and having the necessary technical equipment to use it)\n4. Patients who read, write and understand French\n5. Patients having signed the Patient Informed Consent\n\nExclusion criteria:\n\n1. Patients hospitalized\n2. Patients taking more than 75% of the maximal recommended daily dose of benzodiazepines\n3. Patients taking more than 75% of the maximal recommended daily dose of antipsychotics\n4. Patients taking more than 75% of the maximal recommended daily dose of neuroleptics\n5. Patients who did not respond to 10 different pharmacological treatments\n6. Patients who attempted suicide within the previous last 6 months and presenting with suicidal ideations\n7. Patient presenting with bipolar disorders\n8. Patients with a contra-indication to the device under evaluation:\n\n   * Severe depression requiring hospitalization\n   * Schizophrenic disorders according to DSM 5 classification\n   * Major neurocognitive disorders according to DSM 5 classification\n   * Illiteracy\n   * Subject hospitalized in a healthcare or social institution for reasons other than biomedical research or is deprived of freedom by administrative or judicial decision or is placed under guardianship\n9. Patients unable to read, write and understand French\n10. Patients with no access to a smartphone or a computer with an internet connection\n11. Patients who refuse to sign the Patient Informed Consent\n12. Patients already participating in another interventional clinical study",{"count":50,"type":21},98,"OBSERVATIONAL","The aim of this study is to validate the EmoDTx as a digital tool for mood monitoring in adult patients with unipolar depression. The study is prospective, multicenter, and observational, with a single-arm approach. The device studied, EmoDTx, is a mood-monitoring application that analyzes patients' facial expressions to assess their emotional state. The study aims to compare mood scores obtained via EmoDTx with those of standard depression questionnaires (MADRS, PHQ-9, BDI-II, HAMD-17, QIDS-SR16). It will also provide information on how patients feel about the use of passive monitoring software (without the active involvement of the patient) and how the feedback sent to patients can help in their care.\n\nParticipants who agree to take part in the study, during a selection visit, will be able to:\n\n1. Install the software on a digital interface (smartphone, computer, etc.) and activate or deactivate it whenever they wish during the 8-week follow-up period.\n2. Attend scheduled appointments at the center (a first appointment, then a second 4 weeks later, and a final at 8 weeks) to complete a series of questionnaires, be questioned by the doctor, and fill in other questionnaires on their own.\n3. At home, answer questionnaires independently, 2 weeks and 6 weeks after the first appointment.\n4. The application's feedback will be deactivated during the first 4 weeks and then reactivated during the final 4 weeks.\n5. In parallel, an ancillary study will be conducted on 16 patients enrolled in EMC2FR who accepted and performed the video recording of their structured clinical interview following SCID-5-CV at baseline and 4 weeks.",[54,27,55],"Unipolar Depression","Depression","2025-07-21",{"date":58,"type":32},"2025-07-22",{"date":60,"type":32},"2025-07-15",{"date":62,"type":21},"2025-12-09",{"name":38,"class":39},""]