Cost-utility Analysis of Maintenance rTMS for Treatment-resistant Depression
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 119
- 试验地点
- 25
- 主要终点
- Cost-utility ratio, according to collective perspective of rTMS use in TRD compared to conventional therapeutic approaches without active rTMS.
研究概览
简要总结
Treatment resistant depression (TRD) is a frequent, debilitating condition mostly treated by antidepressants. Repeated magnetic transcranial stimulation (rTMS) has proven adjuvant efficacy in TRD in the acute phase of treatment with a very good tolerance and acceptability. Maintenance rTMS (mTMS) is a strategy consisting in adding regular single TMS sessions after response to an acute course in order to keep the benefit of initial treatment over several month or years. Demonstrating that rTMS is efficient to improve long-term prognosis and decrease economic burden would have a tremendous impact in clinical practice in psychiatry. Thus the investigator's aim is to analyze the long term impact of mTMS treatment on costs, but also quality of life and clinical issues.
详细描述
TRD is associated with enormous social, economic, and personal costs. In literature, psychosocial and pharmacological interventions showed limited one year long-term efficacy in terms of relapse (only 10% of sustained remission at one-year follow-up actually) and quality of life due to refractoriness, observance and adverse effects. In the recent years the field of non-invasive brain stimulation became more mature with an increasing level of evidence reaching Level 1 for rTMS as curative treatment for depression in international guidelines. It is a safe and well tolerated treatment but with still high relapse rate at 6 month and one year (comparable to those former described for ECT). mTMS is a promising tool (as it was proven for ECT) to achieve sustained response several month after treatment in a significant proportion of patients. Little is known about its long-term economic and social benefit which is a crucial question given its time consuming nature. To date there is no large Randomized Clinical Trial (RCT) assessing the long-term health economic interest or adjuvant mTMS compared to treatment as usual (TAU) alone in unipolar TRD . This study is a double-blind randomized controlled trial aiming at determining a 12 month cost-utility analysis, according to collective perspective, of two different modalities of rTMS (systematic mTMS or curative rTMS in case of relapse) for TRD compared to TAU alone. The secondary aims are to describe 24 month cost-utility, longitudinal clinical issues in terms of mood and quality of life, prognosis factors, as well as TAU actual strategies in that population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Sham rTMS will be used for the arm "without rTMS"
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
- •Major depressive disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 MADRS >19
- •Episode duration: 12 weeks to 3 years.
- •2 to 4 unsuccessful treatment lines (including antidepressants, and potentialization agents lithium and quetiapine) despite adequate dosage and duration (6 weeks stable posology)
- •Ability to consent and express informed consent, to answer questionnaires and to go to follow-up visits.
- •Affiliation to social security
排除标准
- •Bipolar disorder
- •Schizophrenia and other psychotic disorders
- •Mental retardation or developmental disorder
- •Substance abuse or dependence
- •Depression symptoms better explained by medical conditions
- •Neurologic conditions (e.g.,previous epilepsy or unexplained seizures, stroke, trauma, infection, metabolic disease, severe migraines, multiple sclerosis, brain tumor)
- •Presence of at least one contra-indication to rTMS
- •Pregnancy/breast-feeding
- •Patient who previously received 5 lines or more pharmacological treatment for the current episode (excluding symptomatic psychotropic drugs, e.g. benzodiazepines and hypnotics)
- •Former use of electroconvulsive therapy or rTMS within the current episode.
- •Previous failure of adequate ECT (at least 12 well conducted sessions) or rTMS course (at least 20 well conducted sessions) in the medical history.
- •History of at least two courses of ECT, previous need for maintenance ECT.
- •Protection measure : maintenance of justice, tutelage, legal guardianship
- •Woman of childbearing age without effective contraception
- •Liberty deprivation (e.g. incarceration, therapeutic injunction)
结局指标
主要结局
Cost-utility ratio, according to collective perspective of rTMS use in TRD compared to conventional therapeutic approaches without active rTMS.
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, 3 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
- marital status(Baseline,12 months and 24 months)
- Level of depression treatment-resistance(Baseline)
- Cost-utility ratio, according to collective perspective of rTMS use in TRD compared to conventional therapeutic approaches without active rTMS.(24 months)
- Relapse-free survival(12 months and 24 months)
- professional status(Baseline,12 months and 24 months)
- Remission rate(12 months and 24 months)
- MADRS score(Baseline, 2 months, 6 months , 9 months, 12 months, 18 months, 24 months)
- Clinical Global Impression (CGI) score(Baseline, 2 months, 6 months , 9 months, 12 months, 18 months, 24 months)
- Treatments combination(s)(Baseline, 2 months, 6 months , 9 months, 12 months, 18 months, 24 months)
- Treatment(s) dose increase(Baseline, 2 months, 6 months , 9 months, 12 months, 18 months, 24 months)
- Budget impact analysis of spreading the most efficient strategy for using rTMS (systematic mTMS or rTMS course in case of relapse).(5 years)
- Major depressive disorder history(Baseline)
- Response rate(12 months and 24 months)
- Beck Depression Inventory (BDI) score(Baseline, 2 months, 6 months , 9 months, 12 months, 18 months, 24 months)
- Adverse events linked to the medical treatment for depression(24 months)
- Number of days between the successive rTMS courses(24 months)
- Patient acceptability of the rTMS technique: Analog Visual Scale(24 months)
- Declarative drug compliance via the CRS (Clinician Rating Scale)(baseline, 12 months and 24 months)
- Treatment(s) switch(es)(Baseline, 2 months, 6 months , 9 months, 12 months, 18 months, 24 months)
- Response rate at the end of rTMS courses(1 month after each rTMS treatments)
- Total number of rTMS sessions(24 months)
- Time between relapses(24 months)
- Declarative drug compliance via the MARS (Medication Adherence Report Scale)(baseline, 12 months and 24 months)
- Rate of suicide attempts and suicides(12 months and 24 months)
- Patient's quality of life(baseline,12 months and 24 months)
- Remission rate at the end of rTMS courses(1 month after each rTMS treatments)
- Compliance with rTMS(24 months)