Status:
TERMINATED
Mirtazapine in Cancer-related Poly-symptomatology
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Cancer
Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 5...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 17 2021
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04763135
Start Date
December 15 2021
End Date
December 17 2021
Last Update
June 8 2023
Active Locations (11)
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1
Centre Hospitalier Universitaire de Clermont-Ferrand
Cébazat, France, 63118
2
Centre Hospitalier Universitaire de Grenoble
La Tronche, France, 38700
3
Hôpital Edouard Herriot
Lyon, France, 69003
4
Hôpital de la Croix-Rousse
Lyon, France, 69004