Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT04763135
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).
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04763135
Study Brief:
Protocol Section:
NCT04763135