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

Официальное название

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

Обзор

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.

Вмешательства

• Устройство EMOCARE 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.

Первичные конечные точки

• Change of scores EMOCARE [Срок оценки: From baseline to 6 weeks]
• Change of scores PHQ-9 self-administrered [Срок оценки: From baseline to 6 weeks]

Вторичные конечные точки (12)

• Score EMOCARE [Срок оценки: At baseline, at 2 weeks, at 4 weeks]
• Change of EMOCARE score [Срок оценки: From baseline to 2 weeks, from baseline to 4 weeks]
• Score PHQ-9 self administered [Срок оценки: At baseline, at 2 weeks, at 4 weeks, at 6 weeks]
• Change of score PHQ-9 self administered [Срок оценки: From baseline to 2 weeks, From baseline to 4 weeks]
• Score PHQ-9 administered by an investigator [Срок оценки: At baseline, at 6 weeks]
• Change of score PHQ-9 administered by an investigator [Срок оценки: From baseline to 6 weeks]
• Score MADRS administered by an investigator [Срок оценки: At baseline, at 6 weeks]
• Change of MADRS administered by an investigator [Срок оценки: From baseline to 6 weeks]
• Score BDI-II [Срок оценки: At baseline, at 6 weeks]
• Change of BDI-II [Срок оценки: From baseline to 6 weeks]
• Score BDI-II [Срок оценки: At baseline, at 2 weeks, at 4 weeks, at 6 weeks]
• Change of BDI-II [Срок оценки: From baseline to 2 weeks, from baseline to 4 weeks, from baseline to 6 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 11 центров

• Private psychiatric practice — Agen
• Private psychiatric pratice — Caen
• Centre Psychothérapique de Nancy — Laxou
• Private psychiatric practice — Maxéville
• Private psychiatric practice — Nantes
• Centre Hospitalier Universitaire de Nantes — Nantes
• Private psychiatric practice — Paris
• Private psychiatric practice — Reims
• … и ещё 3 центра

Идентификаторы

NCT: NCT06601140 · EB-EMC1-2024 · 2024-A01487-40

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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