Clinical trial NCT03872492: Major Depressive Disorder: Early Prediction of Non-response to Antidepressant Therapy Via a Mobile Digital Scale
Official title: Major Depressive Disorder: Early Prediction of Non-response to Antidepressant Therapy Via a Mobile Digital Scale
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Depressive Disorder, Major
Keywords: REDRESS
Depression
Application
Mobile
Lead sponsor: Ad scientiam
Sponsor class: OTHER
First posted: 2019-03-13
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility 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 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)

Exclusion criteria:

* 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)

Primary outcomes:
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).
timeFrame: From Day 0 to Week 2
Secondary outcomes:
measure: 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).
timeFrame: From Day 0 to Week 6
measure: 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.
timeFrame: From Week 6 to Week 8
measure: 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.
timeFrame: From Week 6 to Week 12
measure: 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
timeFrame: Between Week 6 and Week 12
measure: 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
timeFrame: Between Week 2 and Week 8
measure: Build up a composite score (the REDRESS digital score), from the item(s) identified in the previous objectives.
timeFrame: Week 2, Week 6, Week 8 and Week 12
measure: Evaluate patients' adherence to the mobile application
timeFrame: From Day 0 to Week 12
measure: Evaluate the adverse events of the mobile application use.
timeFrame: From Day 0 to Week 12
measure: Collect patients and investigators feedback (usability, satisfaction) on the REDRESS mobile application
timeFrame: Week 12
measure: Evaluate patient's social relationship
timeFrame: Day 0, Week 6 and Week 12
measure: Evaluate patient's quality of life
timeFrame: Day 0, Week 6 and Week 12
measure: Evaluate the patient's quality of life evolution
timeFrame: From Day 0 to Week 12
measure: Evaluate patient's social relationship evolution
timeFrame: From Day 0 to Week 12
measure: Explore correlation between patient's quality of life and REDRESS score
timeFrame: Day 0, Week 6 and Week 12
measure: Evaluate patient's quality of life
timeFrame: Day 0, Week 6 and Week 12
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
city: Grenoble
country: France
facility: CHU Grenoble
city: Nantes
country: France
facility: CHU Nantes - CAPPA Jacques Prévet
city: Nice
country: France
facility: CHU de Nice
city: Paris
country: France
facility: Centre hospitalier Saint-Antoine
city: Paris
country: France
facility: Hôpital de la Pitié Salpêtrière
city: Poitiers
country: France
facility: Centre hospitalier Henri Laborit
city: Rennes
country: France
facility: Centre Hospitalier Guillaume Régnier
city: Toulouse
country: France
facility: CHU Toulouse
city: Tours
country: France
facility: CHRU Tours
Study officials:
affiliation: Pitié-Salpêtrière Hospital
name: Bruno MILLET, Prof
role: PRINCIPAL_INVESTIGATOR
References: