An interventional study of Digital Assessment on mobile in Depressive Disorder, Major, sponsored by Ad scientiam. Terminated at 10 sites in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-03-03.
Sponsored by Ad scientiam · Not applicable, Interventional, and Other
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.
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
This study's enrollment of 92 is above the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.
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Non inclusion Criteria:
Exclusion criteria:
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.
Other: Digital Assessment on mobile
The digital assessment is composed on 5 tests: * "My daily survey" * "My evaluation" * "My cognition" * "My emotions" * "My voice" Data will also be collected passively.
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).
Time frame: From Day 0 to Week 2
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).
Time frame: 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.
Identification of items will be based on the diagnostic performance (AUC).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Day 0, Week 6 and Week 12
This study is terminated, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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