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

69HCL20_0032

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.

2021-12-15

2021-12-17

2021-12-17

Terminated

Early phase I

1

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). * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 1, 'type': 'ACTUAL'}}

2023-06-08