Mirtazapine in Cancer-related Poly-symptomatology (MIR-P)

Civil Hospices of Lyon

Status and phase: Terminated; Phase 3

Conditions: Neoplasms; Neoplasm Metastasis; Cancer

Treatments: Drug: Escitalopram; Drug: Mirtazapine

Study type: Interventional

Funder types: Other

Identifiers

NCT04763135

69HCL20_0032

2020-002994-90 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

Oral mirtazapine

Experimental group

Description:

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.

Treatment:

Drug: Mirtazapine

Oral escitalopram

Active Comparator group

Description:

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.

Treatment:

Drug: Escitalopram