Transcranial Direct Current Stimulation (tDCS) Cost-utility-analysis in Medical Care on Depressive Episode With One Drug Therapy Failure.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 214
- 试验地点
- 16
- 主要终点
- Cost-utility ratio, according to collective perspective of tDCS use in depression compared to usual care without active tDCS.
研究概览
简要总结
The purpose of this study is to determine the transcranial direct current stimulation (tDCS) cost-utility in the depression therapy.
This is a 3 years medico-economics study with 1 year follow-up period involving patients with 1 or 2 depression treatment(s) failed.
Eligible subject will be randomized in 2 groups, usual care with tDCS cure (arm A) or only usual care (arm B).
详细描述
Transcranial direct current stimulation is a non-invasive brain neuromodulation technique. tDCS can be a new therapy in depression.
This study focuses on tDCS cost-utility-analysis. Each patient is following during 12 months. Patients are randomized in 2 arms. Arm A usual care with tDCS cure or arm B usual care without tDCS.
Patient in arm A get a initial tDCS cure one week after randomization. If these patients are answering to the treatment, they can have a new cure in case of relapse. This new cure can start from the second month following initial treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Depression according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) with 1 or 2 failed antidepressant treatments for the current episode.
- •MADRS score superior or equal to
- •Patient agreeing to participate in the study
- •Patient able to answer questionnaires and able to go at research center for follow-up visit.
- •Patient with social insurance
排除标准
- •Electroconvulsive therapy or repetitive transcranial magnetic stimulation for current depressive episode.
- •Depressive episode with psychotic symptoms or mixed.
- •Schizophrenia or addiction to another substance than nicotine
- •Severe neurological disorder (like epilepsy, neurological affect, neurological disease)
- •Severe and / or progressive somatic pathology (leave to the investigator judgment) preventing from participation in the study.
- •tDCS specific contraindications (intracerebral metallic implant, pacemaker)
- •Pregnancy or breast feeding.
- •Woman of childbearing age without contraception (hormonal or with medical device).
- •Participation in another interventional clinical trial
- •legal protection
- •Persons incarcerated or in obligation of treatment / medical treatment order.
结局指标
主要结局
Cost-utility ratio, according to collective perspective of tDCS use in depression compared to usual care without active tDCS.
时间窗: 12 months
The utility will be measured by : Quality Adjusted Life Year (QALYs) as estimated from responses to the Euroqol-5 Dimensions (EQ-5D) health-related quality of life questionnaire. The questionnaire focuses on 5 dimensions: mobility, personal autonomy, current activities, pain/discomfort and anxiety/depression. For each of these dimensions, 5 answers are possible. The costs will be measured by the addition of the following costs: Drugs dispensing via Health insurance database "National system of information of the French health insurance" (SNIIRAM), hospitalizations, work stoppages and care consumption collected in a declarative patient questionnaire.
次要结局
- Compliance with tDCS(12 months)
- Budget impact analysis of spreading the most efficient strategy for using tDCS(5 years)
- Rate of suicides(12 months)
- Declarative drug compliance via the MARS (Medication Adherence Report Scale)(at baseline and at 12 months)
- Impact of the implementation of the tDCS on the organization of care(12 months)
- Response rate(at baseline, at the end of each tDCS cure (for Arm A patients) through study completion (12 months) and at 12 months for all patients)
- Total number of tDCS sessions(12 months)
- Relapse-free survival(12 months)
- MOCA Score (Montreal Cognitive Assessment)(At Baseline, one month, 2 months, 6 months and 12 months.)
- Rate of suicide attempts(12 months)
- Treatment(s) dose increase(At Baseline, one month, 2 months, 6 months and 12 months.)
- Declarative drug compliance via the CRS (Clinician Rating Scale)(at baseline and at 12 months)
- Number of days between the successive tDCS cures(12 months)
- Adverse events linked to tDCS(12 months)
- Remission rate(12 months)
- MADRS score(At Baseline, one month, 2 months, 6 months and 12 months.)
- Beck Depression Inventory (BDI) score(At Baseline, one month, 2 months, 6 months and 12 months.)
- Treatment(s) switch(es)(At Baseline, one month, 2 months, 6 months and 12 months.)
- professional status(At baseline)
- Clinical Global Impression (CGI) score(At Baseline, one month, 2 months, 6 months and 12 months.)
- Adverse events linked to the medical treatment for depression(12 months)
- Treatments combination(s)(at Baseline, one month, 2 months, 6 months and 12 months.)
- Patient acceptability of the tDCS technique: Analog Visual Scale(at the end of the first tDCS cure (up to one month))