Mirtazapine in Cancer-related Poly-symptomatology (MIR-P)
Cancer, Neoplasms, Neoplasm Metastasis
About this trial
This is an interventional treatment trial for Cancer focused on measuring Cancer, Symptom management, Poly-Symptomatology, Mirtazapine, Antidepressive drugs
Eligibility Criteria
Inclusion Criteria:
- 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 11.
- 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 14.
- Having a social security affiliation.
Exclusion Criteria:
- 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).
- Antipsychotic drugs (phenothiazine antipsychotics, pimozide, haloperidol)
- 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 Cimetidine
- Ticlopidine
- Metoprolol
- Methadone
- Ketamine
- Triptan drugs
- Dapoxetine
- St. John's wort
- Antidepressant drug
- Any other medication known to cause prolonged QT intervals.
- 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
Sites / Locations
- Centre Hospitalier Universitaire de Clermont-Ferrand
- Centre Hospitalier Universitaire de Grenoble
- Hôpital Edouard Herriot
- Hôpital de la Croix-Rousse
- Centre Médico-Chirurgical de Réadaptation des Massues Croix-Rouge française
- Centre Léon Bérard
- Institut Curie
- Centre Hospitalier Lyon Sud
- Centre Hospitalier Universitaire de Saint-Etienne
- Hôpitaux universitaires de Strasbourg
- Centre Hospitalier de Valence
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Oral mirtazapine
Oral escitalopram
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.
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.