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Major Depressive Disorder: Early Prediction of Non-response to Antidepressant Therapy Via a Mobile Digital Scale (REDRESS)

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ClinicalTrials.gov Identifier: NCT03872492
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : October 30, 2019
Sponsor:
Information provided by (Responsible Party):
Ad scientiam

Brief Summary:

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:

  • Improvement in emotional processing of happy facial expressions after 1 week of treatment,
  • Circa 20% improvement in Hamilton Depression Rating Scale-17 item (HDRS-17) at week 2. The hypothesis is therefore that repeated, systematic and real-time, contextualized and multimodal collection of depressive symptoms from patients at home will establish a threshold score that can predict a subsequent response to their treatment.

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.


Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Other: Digital Assessment on mobile Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Major Depressive Disorder: Early Prediction of Non-response to Antidepressant Therapy Via a Mobile Digital Scale
Actual Study Start Date : October 17, 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants

Arm Intervention/treatment
Experimental: Patients with Major Depressive Disorder

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 more than one 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.





Primary Outcome Measures :
  1. 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). [ Time Frame: From Day 0 to Week 2 ]
    Identification of items will be based on the diagnostic performance (AUC).


Secondary Outcome Measures :
  1. 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). [ Time Frame: From Day 0 to Week 6 ]
    Identification of items will be based on the diagnostic performance (AUC).

  2. 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. [ Time Frame: From Week 6 to Week 8 ]
    Identification of items will be based on the diagnostic performance (AUC).

  3. 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. [ Time Frame: From Week 6 to Week 12 ]
    Identification of items will be based on the diagnostic performance (AUC).

  4. 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 [ Time Frame: Between Week 6 and Week 12 ]
    Intra patient comparison will be based on a paired comparison test.

  5. 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 [ Time Frame: Between Week 2 and Week 8 ]
    Intra patient comparison will be based on a paired comparison test.

  6. Build up a composite score (the REDRESS digital score), from the item(s) identified in the previous objectives. [ Time Frame: Week 2, Week 6, Week 8 and Week 12 ]

    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.


  7. Evaluate patients' adherence to the mobile application [ Time Frame: From Day 0 to Week 12 ]
    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.

  8. Evaluate the adverse events of the mobile application use. [ Time Frame: From Day 0 to Week 12 ]
    Mobile application safety will be assessed by a descriptive analysis.

  9. Collect patients and investigators feedback (usability, satisfaction) on the REDRESS mobile application [ Time Frame: Week 12 ]
    Descriptive analysis of patients and investigators satisfaction relating to the mobile application collected with satisfaction questionnaires

  10. Evaluate patient's social relationship [ Time Frame: Day 0, Week 6 and Week 12 ]
    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.

  11. Evaluate patient's quality of life [ Time Frame: Day 0, Week 6 and Week 12 ]
    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.

  12. Evaluate the patient's quality of life evolution [ Time Frame: From Day 0 to Week 12 ]
    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.

  13. Evaluate patient's social relationship evolution [ Time Frame: From Day 0 to Week 12 ]
    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.

  14. Explore correlation between patient's quality of life and REDRESS score [ Time Frame: Day 0, Week 6 and Week 12 ]
    The correlation will be evaluated with the pearson correlation



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 to 70 Years
  • Diagnostic and Statistical Manual of Mental Disorders-5 criteria for MDD
  • Score > 21 on HDRS-17
  • Initiation of an antidepressant treatment for the current episode (first line or second line treatment, ...)
  • Ability to use a mobile application
  • Agreement to use the study mobile if he/she does not own an iPhone 5 or newer
  • Enrolled in or benefiting of a Social Security program
  • Having read the information sheet and signed the informed consent form

Non inclusion Criteria:

  • Serious suicidal risk, identified by the Mini International Neuropsychiatric Interview (MINI)
  • Perinatal depression
  • Seasonal affective disorder
  • Psychiatric comorbidities: bipolar disorder, obsessive-compulsive disorder, post-traumatic stress, psychotic disorder, anorexia nervosa, bulimia nervosa, personality disorder identified by the MINI questionnaire
  • Alcohol addiction or abuse, identified by the MINI questionnaire
  • Substance related disorders non-alcoholic addiction or abuse (opioids, cocaine, cannabis, sedatives, stimulants, hallucinogens, inhalants, solvents), identified by the MINI questionnaire
  • Under psychotherapy or neurostimulation (< 6 months before inclusion day)
  • Patient under Temporary Use Authorisation (TUA)
  • Recent introduction of benzodiazepines at regular doses (< 6 months before inclusion day). Limited use (≤3 consecutive days) is authorized.
  • Patients with Monoamine Oxidase Inhibitor (MAOIs), tricyclic antidepressant or electroconvulsive therapy (ECT) history
  • Patient with a somatic pathology
  • Hospitalised patient
  • Antecedent of major head trauma
  • Seizures
  • Systemic medical diseases that are likely to affect cognitive functioning
  • Pregnant and nursing women
  • Wearers of pacemakers, implantable defibrillators
  • Subjects not proficient in French
  • Person under guardianship or curators
  • Illiterate subjects
  • Participation to another interventional clinical trial (category 1)

Exclusion criteria:

  • Serious suicidal risk, according to clinician's judgement
  • Discontinuation or change of AD treatment during the phase 1 or 2
  • Initiation of a psychotherapy or neurostimulation
  • Alcohol and substances abuse related disorders (opioids, cocaine, cannabis, sedatives, stimulants, hallucinogens, inhalants, solvents), according to clinician's judgement.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03872492


Contacts
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Contact: Bruno MILLET, Prof 01.42.16.28.94 b.millet@aphp.fr

Locations
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France
Centre Hospitalier Saint-Anne Not yet recruiting
Paris, France
Contact: Pierre De MARICOURT, Dr         
Centre hospitalier Saint-Antoine Not yet recruiting
Paris, France
Contact: Florian FERRERI, Dr         
Hôpital de la Pitié Salpêtrière Recruiting
Paris, France
Contact: Bruno MILLET, Prof         
Centre hospitalier Henri Laborit Not yet recruiting
Poitiers, France
Contact: Nematollah JAAFARI, Dr         
Centre Hospitalier Guillaume Régnier Not yet recruiting
Rennes, France
Contact: Dominique DRAPIER, Prof         
Sponsors and Collaborators
Ad scientiam
Investigators
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Principal Investigator: Bruno MILLET, Prof Pitié-Salpêtrière Hospital

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Responsible Party: Ad scientiam
ClinicalTrials.gov Identifier: NCT03872492     History of Changes
Other Study ID Numbers: REDRESS
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: October 30, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ad scientiam:
REDRESS
Depression
Application
Mobile
Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Psychotropic Drugs