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Table 2 Inclusion and non-inclusion criteria

From: What is the effectiveness and safety of mirtazapine versus escitalopram in alleviating cancer-associated poly-symptomatology (the MIR-P study)? A mixed-method randomized controlled trial protocol

Inclusion criteria

Non-inclusion criteria

Being over 18 years old

Being treated with an antidepressant agent during the four weeks before inclusion

Suffering from an advanced cancer

Having had a hypersensivity event to mirtazapine, escitalopram of any excipient

Having a clinically estimated life expectancy over 3 months

Having had a prior inefficient treatment with mirtazapine or escitalopram

Having postural hypotension or arterial systolic hypotension inferior to 90 mmHg measured following the guidelines of the European Society of Cardiology

Being diagnosed from having a depressive syndrome by a Hospital Anxiety and Depression Scale-D over 11

Having a QT interval over 420 ms

Having uncontrolled heart rhythm disorder or uncontrolled conduction disorder

Being in need of an antidepressant treatment

Having had or having bipolar disorder

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, or anxiety

Having uncontrolled seizure or epilepsy (relative non-inclusion criteria needing a neurology specialist opinion)

Having or having a history of closed-angle glaucoma

Having or not a cancer treatment

Having bone marrow aplasia

Being able to understand the information related to the study, and to sign informed consent

Practicing breastfeeding or being pregnant

Having agreed to take part in the study

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: Flecainde, 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 (phenothyazine antipsychotics, pimozide, haloperidol)

- Linezolid, sparfloxacin, moxifloxacin, macrolids (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

Being able to fill Patient Reported Outcomes questionnaires

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

Being available to be called on days 7 and 14

Having end-stage renal disease with a creatinine clearance inferior to 15 ml/min calculated using the Cockroft’s formula

Having hepatic failure

Having a social security affiliation

Having legal incapacity