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

NCT03872492 | Terminated

• 1 other identifier: REDRESS
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 10

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.

Conditions

Depressive Disorder, Major

Keywords

REDRESS; Depression; Application; Mobile

Outcome Measures

Primary Outcomes (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).

  Identification of items will be based on the diagnostic performance (AUC).

  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).

  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.

  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.

  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

  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

  Between Week 2 and Week 8

Study Arms (1)

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.

Other: Digital Assessment on mobile

Interventions

Digital Assessment on mobile OTHER

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.

Patients with Major Depressive Disorder

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• Patient under Temporary Use Authorisation (TUA)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ad scientiam: lead

Study Sites (10)

CHU Clermont-Ferrand

Clermont-Ferrand, France

Location

CHU Grenoble

Grenoble, France

Location

CHU Nantes - CAPPA Jacques Prévet

Nantes, France

Location

CHU de Nice

Nice, France

Location

Centre hospitalier Saint-Antoine

Paris, France

Location

Hôpital de la Pitié Salpêtrière

Paris, France

Location

Centre hospitalier Henri Laborit

Poitiers, France

Location

Centre Hospitalier Guillaume Régnier

Rennes, France

Location

CHU Toulouse

Toulouse, France

Location

CHRU Tours

Tours, France

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Bruno MILLET, Prof

  Pitié-Salpêtrière Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2019
• First Posted: March 13, 2019
• Study Start: October 17, 2019
• Primary Completion: December 29, 2022
• Study Completion: December 29, 2022
• Last Updated: March 3, 2023

Record last verified: 2023-03

Locations

FR (10)