Clinical trial · Interventional
Mirtazapine in Cancer-related Poly-symptomatology
What is the Effectiveness and Safety of Mirtazapine Versus Escitalopram in Alleviating Cancer-associated Poly-symptomatology (MIR-P)? A Mixed-method Randomized Controlled Trial Protocol
NCT04763135CI-TRIAL-00066987MIR-PterminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): difficulties in recruiting
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Neoplasm Metastasis | — | UNRESOLVED | — |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Escitalopram | Drug | — | UNRESOLVED |
| Mirtazapine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Oral mirtazapine
- 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.
- interventionNames
- Drug: Mirtazapine
- type
- ACTIVE_COMPARATOR
- label
- Oral escitalopram
- 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.
- interventionNames
- Drug: Escitalopram
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDEconomos G, Alexandre M, Perceau-Chambard E, Villeneuve L, Subtil F, Haesebaert J, Glehen O. 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. BMC Palliat Care. 2022 May 23;21(1):84. doi: 10.1186/s12904-022-00976-7. PMID 35599320