Mirtazapine in Cancer-related Poly-symptomatology

• Status: Not yet recruiting
• Trial end date: 2023-05-08
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospices Civils de Lyon
• Treatments: Citalopram; Mirtazapine

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).

• Antipsychotic drugs (phenothiazine antipsychotics, pimozide, haloperidol)

• 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 Cimetidine

• Ticlopidine

• Metoprolol

• Methadone

• Ketamine

• Triptan drugs

• Dapoxetine

• St. John's wort

• Antidepressant drug

• Any other medication known to cause prolonged QT intervals.

• 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