Major Depressive Disorder: Early Prediction of Non-response to Antidepressant Therapy Via a Mobile Digital Scale
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Ad scientiam
- 入组人数
- 92
- 试验地点
- 10
- 主要终点
- 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).
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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)
排除标准
- 未提供
结局指标
主要结局
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).
时间窗: From Day 0 to Week 2
Identification of items will be based on the diagnostic performance (AUC).
次要结局
- Evaluate patient's quality of life(Day 0, Week 6 and Week 12)
- 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)
- Evaluate patients' adherence to the mobile application(From Day 0 to Week 12)
- Collect patients and investigators feedback (usability, satisfaction) on the REDRESS mobile application(Week 12)
- Evaluate patient's social relationship evolution(From Day 0 to Week 12)
- Explore correlation between patient's quality of life and REDRESS score(Day 0, 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)
- Evaluate the patient's quality of life evolution(From Day 0 to Week 12)
- 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)
- Evaluate patient's social relationship(Day 0, Week 6 and Week 12)
- 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)
- Build up a composite score (the REDRESS digital score), from the item(s) identified in the previous objectives.(Week 2, Week 6, Week 8 and Week 12)
- Evaluate the adverse events of the mobile application use.(From Day 0 to Week 12)