What is the Effectiveness and Safety of Mirtazapine Versus Escitalopram in Alleviating Cancer-associated Poly-symptomatology (MIR-P)? A Mixed-method Randomized Controlled Trial Protocol
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 11
- 主要终点
- Global health status score
研究概览
简要总结
Multicenter, prospective, randomized, controlled trial based on a mixed-method methodology using parallel groups, of oral mirtazapine (intervention) compared with oral escitalopram (control), with a 56 days follow-up. Improvement of the Global health Status (issued from the EORTC-QLQ-C30 (Quality of Life Questionnaire)) will be used as the primary outcome on day 56. Semi-structures interviews will be performed on a purposive sample for qualitative analysis. The 418 participants will be followed-up at day 7, 14, 28 and 56 for a 56 days period. A sub-group of participants will be invited to take part into qualitative interviews at baseline and day 56. Recruitment of participants to the qualitative part will be based on a purposive sampling.
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
- •Being over 18 years old
- •Suffering from advanced cancer
- •Having a clinically estimated life expectancy over 3 months.
- •Being diagnosed from having a depressive syndrome by a Hospital Anxiety and Depression Scale-D over
- •Being in need of an antidepressant treatment.
- •Suffering from at least one under-controlled symptom (defined as a score over 3 on the Edmonton Symptom Assessment Scale) among: pain, nausea, vomiting, breathlessness, lack of appetite, sleep disorders, anxiety or impaired wellbeing.
- •Having or not a cancer treatment.
- •Being able to understand the information related to the study, and to sign informed consent.
- •Having agreed to take part to the study.
- •Being able to fill Patient Reported Outcomes questionnaires.
- •Being available to be call on days 7 and
- •Having a social security affiliation.
排除标准
- •Being treated by an antidepressive agent during the four weeks before inclusion.
- •Having had a hypersensitivity event to mirtazapine, escitalopram of any excipient.
- •Having had a prior inefficient treatment by mirtazapine or escitalopram.
- •Having postural hypotension or arterial systolic hypotension inferior to 90 mmHg measured following the guidelines of the European Society of Cardiology
- •Having a QT interval over 420 ms.
- •Having uncontrolled hearth rhythm disorder or uncontrolled conduction disorder.
- •Having had or having bipolar disorder.
- •Having uncontrolled seizure or epilepsy (relative non-inclusion criteria needing a neurology specialist opinion)
- •Having or having history of closed-angle glaucoma.
- •Having bone marrow aplasia.
- •Practicing breast-feeding or being pregnant.
- •Women of childbearing age with no contraception method.
- •Having a treatment with:
- •Monoamine oxidase inhibitors (Selegiline, Moclobemide, Isocarboxazid, Nialamide, Phenelzine, Tranylcypromine, Iproniazid, Iproclozide, Toloxatone, Linezolid, Safinamide, Rasagiline)
- •One of the following antiarrhythmic drugs: Flecainide, Propafenone, any class IA and III antiarrhythmic drug (amiodarone, disopyramide, hydroquinidine, quinidine, procainamide, sparteine, ajmaline, prajmaline, lorajmine, bretylium tosilate, bunaftine, dofetilide, ibutilide, tedisamil, dronedarone).
- •Linezolid, sparfloxacin, moxifloxacin, macrolides (IV erythromycin, josamycin, clarithromycin, telithromycin), pentamidin, halofantrine, HIV protease inhibitors (ritonavir, nelfinavir, amprenavir, indinavir), azolic antifungal agents (ketoconazole, itraconazole, miconazole, fluconazole, voriconazole)
- •Mizolastine and Astémizole
- •St. John's wort
- •Having genetic galactose intolerance or glucose-galactose malabsorption.
- •Having one of the following electrolyte disorders not corrected at the time of inclusion: hyponatremia, hyperkalemia, hypokalemia, hypermagnesemia, and hypomagnesemia.
- •Having end-stage renal disease with a creatinine clearance inferior to 15 ml/min calculated using the Cockroft's formula.
- •Having hepatic failure.
- •Having legal incapacity
研究组 & 干预措施
Oral mirtazapine
Arm 1 patients will be treated using a daily mirtazapine treatment. Treatment will be taken on the evening. Treatment will be initiated at 15 mg daily and gradually increased depending on symptom control and side effects. Treatment doses will be adapted for old patients and those with liver failure.
干预措施: Mirtazapine (Drug)
Oral escitalopram
Arm 2 patients will be treated using a daily escitalopram treatment. Treatment will be taken in the morning. Treatment will be initiated at 10 mg daily and gradually increased depending on symptom control and side effects. Treatment doses will be adapted for 5 mg for old patients.
干预措施: Escitalopram (Drug)
结局指标
主要结局
Global health status score
时间窗: At baseline and day 56
The Global Health Status will be calculated from the specific subscale included in the EORTC-QLQ-C30 scale. The difference between baseline and the end-point (day 56) will be the primary judgment criteria. A 4 to 8 points difference between baseline and endpoint will be considered as a mild difference, and a difference over 8 points will be considered as a moderate difference.
次要结局
- The subjective experience associated with symptoms burden.(At baseline and day 56.)
- Proportion of mitigated symptoms.(Day 56)
- Auto-assessment depression score.(Day 56)
- Hetero-assessment-based depression score.(Day 56)
- Weight control(Day 56)
- Weight improvement.(Day 56)
- Stability in oral morphine milligram equivalents.(Day 56)
- Escalation in symptom control treatment doses(Day 56)
- Number of side effects.(Day 56)
- Medication adherence.(Day 56)
- Symptoms' intensities auto-assessment on the following symptoms: pain, nausea, vomiting, lack of appetite, breathlessness, depression, anxiety, sleep disorders and wellness.(Day 56)