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The study was stopped prematurely because the total number of analyzable patients for the primary objective to be included was reached.
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Major Depressive Disorder (MDD) is a debilitating disease characterized by a depressed mood, diminished interests, impaired cognitive function and vegetative symptoms, such as disturbed sleep or appetite. MDD occurs about twice as often in women than it does in men and affects about 6% of the adult population worldwide each year.
Standard symptoms scales like the Hamilton Depression Rating Scale or the Montgomery-asberg Depression Rating Scale, the Self-Report 16-item Quick Inventory of Depressive Symptomatology were initially developed for the evaluation of a therapeutic intervention or a pharmacological treatment and are routinely used by clinicians in the assessment of Treatment Resistant Depression (TRD) occurrence. In parallel, patient-reported outcomes have gained increasing importance and are widely recommended by health authorities in the assessment of depression. The same institutions insist on the collection of real-world data to provide clinicians with ecological measurements. It has been demonstrated that an early response to an AntiDepressant (AD) treatment can be seen as early as week 2 and is not related to a placebo-effect. While there is no consensus on the exact cut-off values, several factors emerge as early predictors of a later treatment response, such as:
REDRESS was inspired by several standard depression scales used and recommended by the French Health Authority, augmented with digital active and passive activity monitoring, speech analysis and emotional processing assessment. Another important assumption is that honesty and willingness to disclose personal or embarrassing things will be best achievable via a digital solution.
To test this assumption, the overall scores and each subscores on the REDRESS numerical scale will be compared in people with MDD showing adequate response to those showing insufficient response.
The response to treatment at week 6 will be studied (end of Phase 1). Non-responders and responders to the first treatment round will be enrolled in a 6-week extension phase (Phase 2). Non-responders will receive another treatment course (Other AD, combination, etc.). Responders will just be followed up and will keep the same treatment. The REDRESS scores will be analysed in this population and will allow us to test the investigator's assumption in people with treatment resistant depression. This study will also allow to assess patients' quality of life at the end of each phase of treatment and to compare results with REDRESS scores.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Major Depressive Disorder | Experimental | Patients will be followed for 12 weeks. Hospital visits will be made at week 2 and week 6 (Phase1) as well as week 8 and week 12 (Phase 2). At the end of phase 1 if the patient is considered as an responder he will make one more visit at week 12. If the patient is considered as non-responder, he will make 2 other visits: at week 8 and week 12. Between each visit, the patient will perform REDRESS application assessments every day for "My daily survey" and every 3 days for the other assessments. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital Assessment on mobile | Other | The digital assessment is composed on 5 tests:
Data will also be collected passively. |
| Measure | Description | Time Frame |
|---|---|---|
| Show that responders and non-responders in phase 1, have a different early profile on some of the items assessed by REDRESS at week 2 (or before) and identify the predictor item(s). | Identification of items will be based on the diagnostic performance (AUC). | From Day 0 to Week 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Show that responders and non-responders in phase 1 have a different profile on some of the items assessed by REDRESS at week 6 and identify the discriminating item(s). | Identification of items will be based on the diagnostic performance (AUC). | From Day 0 to Week 6 |
| Reproducibility: show that responders and non-responders in phase 2 have a different profile on some of the items assessed by REDRESS at week 8 and identify the same predictor item(s) found in phase 1. |
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Inclusion Criteria:
Non inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruno MILLET, Prof | Pitié-Salpêtrière Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand | Clermont-Ferrand | France | ||||
| CHU Grenoble |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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Identification of items will be based on the diagnostic performance (AUC). |
| From Week 6 to Week 8 |
| Reproducibility: show that responders and non-responders in phase 2 have a different profile on some of the items assessed by REDRESS at week 12 and identify the same discriminating item(s) found in phase 1. | Identification of items will be based on the diagnostic performance (AUC). | From Week 6 to Week 12 |
| Intra-patient comparison phase 1 / phase 2: show that patients non-responding in phase 1 and responding in phase 2 have a different profile on some of the items assessed by REDRESS | Intra patient comparison will be based on a paired comparison test. | Between Week 6 and Week 12 |
| Intra-patient comparison phase 1 / phase 2: show that patients non-responding in phase 1 and responding in phase 2 have a different profile on some of the items assessed by REDRESS | Intra patient comparison will be based on a paired comparison test. | Between Week 2 and Week 8 |
| Build up a composite score (the REDRESS digital score), from the item(s) identified in the previous objectives. | Ability of the REDRESS digital score to identify responders and non-responders will be based on the diagnostic performance. The REDRESS digital score will be built using the 5 assessments: "My Daily Survey", My Evaluation", "My Cognition", "My Emotion", My Voice" and passive data collection. This score will be constructed during the study. | Week 2, Week 6, Week 8 and Week 12 |
| Evaluate patients' adherence to the mobile application | Patients' adherence to the REDRESS mobile application will be based on the number of questionnaires administered and completed and the number of variables collected via the mobile application as a function of time of follow-up. | From Day 0 to Week 12 |
| Evaluate the adverse events of the mobile application use. | Mobile application safety will be assessed by a descriptive analysis. | From Day 0 to Week 12 |
| Collect patients and investigators feedback (usability, satisfaction) on the REDRESS mobile application | Descriptive analysis of patients and investigators satisfaction relating to the mobile application collected with satisfaction questionnaires | Week 12 |
| Evaluate patient's social relationship | The quality of life will be measure with the form "Work and Social Adjustment Scale" (WSAS). This scale measures : ability to work, home management, social leisure activities, private leisure activities and close relationships. A WSAS score above 20 appears to suggest moderately severe or worse psychopathology. Scores between 10 and 20 are associated with significant functional impairment but less severe clinical symptomatology. Scores below 10 appears to be associated with subclinical populations. The maximum score of the WSAS is 40. | Day 0, Week 6 and Week 12 |
| Evaluate patient's quality of life | The quality of life will be measure with the form "Quality of Life Enjoyment". This questionnaire is designed to help assess the degree of enjoyment and satisfaction experienced during the past week. This scale mesures : physical health, mood, work, household activities, social relationship, family relationship, leisure time activities, ability to function in daily life, sexual drive, living situation, ability to do work or hobbies, medication. | Day 0, Week 6 and Week 12 |
| Evaluate the patient's quality of life evolution | The quality of life will be measure with the form "Work and Social Adjustment Scale" (WSAS). This scale measures : ability to work, home management, social leisure activities, private leisure activities and close relationships. A WSAS score above 20 appears to suggest moderately severe or worse psychopathology. Scores between 10 and 20 are associated with significant functional impairment but less severe clinical symptomatology. Scores below 10 appear to be associated with subclinical populations. The maximum score of the WSAS is 40. | From Day 0 to Week 12 |
| Evaluate patient's social relationship evolution | The quality of life will be measure with the form "Quality of Life Enjoyment". This questionnaire is designed to help assess the degree of enjoyment and satisfaction experienced during the past week. This scale mesures : physical health, mood, work, household activities, social relationship, family relationship, leisure time activities, ability to function in daily life, sexual drive, living situation, ability to do work or hobbies, medication. | From Day 0 to Week 12 |
| Explore correlation between patient's quality of life and REDRESS score | The correlation will be evaluated with the pearson correlation | Day 0, Week 6 and Week 12 |
| Evaluate patient's quality of life | The quality of life will be measure with the form "Dimensional Anhedonia Rating Scale". This scale measure anhedonia in the context of Major Depressive Disorder. The DARS assesses anhedonia across 4 domains: Hobbies, Food/Drink, Social Activities and Sensory Experiences. The total score of the DARS ranges from 0-68. | Day 0, Week 6 and Week 12 |
| Grenoble |
| France |
| CHU Nantes - CAPPA Jacques Prévet | Nantes | France |
| CHU de Nice | Nice | France |
| Centre hospitalier Saint-Antoine | Paris | France |
| Hôpital de la Pitié Salpêtrière | Paris | France |
| Centre hospitalier Henri Laborit | Poitiers | France |
| Centre Hospitalier Guillaume Régnier | Rennes | France |
| CHU Toulouse | Toulouse | France |
| CHRU Tours | Tours | France |
| D001519 |
| Behavior |