Depressive Disorder, MajorREDRESSNCT03872492
Major Depressive Disorder: Early Prediction of Non-response to Antidepressant Therapy Via a Mobile Digital Scale
A study testing Digital Assessment on mobile in people with Depressive Disorder, Major, run by Ad scientiam at 10 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- Digital Assessment on mobile
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 10 sitesFrance
- Study dates
- 17 Oct 2019to 29 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 30Show fewer
- 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 neurostimulation (< 6 months before inclusion day)
- Patient under Temporary Use Authorisation (TUA)
- Patients with Monoamine Oxidase Inhibitor (MAOIs), tricyclic antidepressant
- Patient with electroconvulsive therapy (ECT) history for current episode
- Patient with a somatic pathology
- Scheduled hospitalization for more than 7 days
- 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)
Who cannot join
- Serious suicidal risk, according to clinician's judgement
- Discontinuation or change of AD treatment before 4 weeks after the dose initiation in the phase 1 and 2
- Initiation of a structured psychotherapy or neurostimulation
- Initiation of treatment with MAOIS
- Introduction of benzodiazepines at regular doses. Limited use (≤7 consecutive days or several periods of ≤3 consecutive days) is authorized
- Alcohol and substances abuse related disorders (opioids, cocaine, cannabis, sedatives, stimulants, hallucinogens, inhalants, solvents), according to clinician's judgement.
- Patient under Temporary Use Authorisation (TUA)
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
CHU Clermont-Ferrand
Clermont-Ferrand
CHU Grenoble
Grenoble
CHU Nantes - CAPPA Jacques Prévet
Nantes
CHU de Nice
Nice
Centre hospitalier Saint-Antoine
Paris
Hôpital de la Pitié Salpêtrière
Paris
Centre hospitalier Henri Laborit
Poitiers
Centre Hospitalier Guillaume Régnier
Rennes
CHU Toulouse
Toulouse
CHRU Tours
Tours
About this study
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:
Read more
- 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.
- Conditions
- Depressive Disorder, Major
- Being tested
- Digital Assessment on mobile
- Keywords
- REDRESS, Depression, Application, Mobile
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Assessment on mobileOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Digital Assessment on mobile |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From Day 0 to Week 2
Secondary outcomes (15)
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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Day 0, Week 6 and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start17 Oct 2019
- Primary completion29 Dec 2022
- Study completion29 Dec 2022
Why it stopped: The study was stopped prematurely because the total number of analyzable patients for the primary objective to be included was reached.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ad scientiam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruno MILLET, Prof, Principal investigator, Pitié-Salpêtrière Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03872492
- Sponsor's protocol ID
- REDRESS
- Acronym
- REDRESS
- Status last verified
- Mar 2023
- First submitted
- 27 Feb 2019
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Major Depressive Disorder: Early Prediction of Non-response to Antidepressant Therapy Via a Mobile Digital Scale
- ClinicalTrials.gov ID
- NCT03872492
- Acronym / sponsor ID
- REDRESS / REDRESS
- Conditions
- Depressive Disorder, Major
- Keywords
- REDRESS, Depression, Application, Mobile
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped prematurely because the total number of analyzable patients for the primary objective to be included was reached.
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Ad scientiamUniversity, hospital or other
- Study start
- 17 Oct 2019 (actual)
- Primary completion
- 29 Dec 2022 (actual)
- Study completion
- 29 Dec 2022 (actual)
- First posted
- 13 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Major Depressive Disorder | Experimental | Other: Digital Assessment on mobilePatients 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- 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
Key exclusion criteria (7 listed)
- Serious suicidal risk, according to clinician's judgement
- Discontinuation or change of AD treatment before 4 weeks after the dose initiation in the phase 1 and 2
- Initiation of a structured psychotherapy or neurostimulation
- Initiation of treatment with MAOIS
- Introduction of benzodiazepines at regular doses. Limited use (≤7 consecutive days or several periods of ≤3 consecutive days) is authorized
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Assessment on mobileThe digital assessment is composed on 5 tests: * "My daily survey" * "My evaluation" * "My cognition" * "My emotions" * "My voice" Data will also be collected passively. | Other | Patients with Major Depressive Disorder |
Primary outcome
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).
15 secondary outcomes
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
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
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
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 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
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
Evaluate patients' adherence to the mobile application
Time frame: From Day 0 to Week 12
Evaluate the adverse events of the mobile application use.
Time frame: From Day 0 to Week 12
Collect patients and investigators feedback (usability, satisfaction) on the REDRESS mobile application
Time frame: Week 12
Evaluate patient's social relationship
Time frame: Day 0, Week 6 and Week 12
Evaluate patient's quality of life
Time frame: Day 0, Week 6 and Week 12
Evaluate the patient's quality of life evolution
Time frame: From Day 0 to Week 12
Evaluate patient's social relationship evolution
Time frame: From Day 0 to Week 12
Explore correlation between patient's quality of life and REDRESS score
Time frame: Day 0, Week 6 and Week 12
Evaluate patient's quality of life
Time frame: Day 0, Week 6 and Week 12
Results and safety
The study was stopped early (reason given: The study was stopped prematurely because the total number of analyzable patients for the primary objective to be included was reached.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno MILLET, Prof principal investigator
Pitié-Salpêtrière Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Assessment on mobile in people with Depressive Disorder, Major, run by Ad scientiam at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 30 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was stopped prematurely because the total number of analyzable patients for the primary objective to be included was reached.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2023.