- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04763135
Mirtazapine in Cancer-related Poly-symptomatology (MIR-P)
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Guillaume ECONOMOS, MD
- Phone Number: +33 06.68.05.71.46
- Email: Guillaume.economos@chu-lyon.fr
Study Contact Backup
- Name: Elise PERCEAU-CHAMBARD, MD
- Phone Number: +33 04.78.86.41.48
- Email: elise.perceau-chambard@chu-lyon.fr
Study Locations
-
-
-
Cébazat, France, 63118
- Centre Hospitalier Universitaire de Clermont-Ferrand
-
La Tronche, France, 38700
- Centre Hospitalier Universitaire de Grenoble
-
Lyon, France, 69008
- Centre Leon Berard
-
Lyon, France, 69003
- Hôpital Edouard Herriot
-
Lyon, France, 69004
- Hopital de la Croix-Rousse
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Lyon, France, 69005
- Centre Médico-Chirurgical de Réadaptation des Massues Croix-Rouge française
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Paris, France, 75005
- Institut Curie
-
Pierre-Bénite, France, 69495
- Centre Hospitalier Lyon Sud
-
Saint-Étienne, France, 42100
- Centre Hospitalier Universitaire de Saint-Étienne
-
Strasbourg, France, 67098
- Hôpitaux Universitaires de Strasbourg
-
Valence, France, 26000
- Centre Hospitalier de Valence
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Oral mirtazapine
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.
|
Orally disintegrating tablets of mirtazapine introduced at the dose of 15 mg and increased up to 45 mg per day during 56 days. Doses escalation: based on symptom management and side effect assessment. |
Active Comparator: Oral escitalopram
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.
|
Orally disintegrating tablets of escitalopram introduced at the dose of 10 mg (or 5 mg for patients older than 65) and increased up to 20 mg per day during 56 days. Doses escalation: based on symptom management and side effect assessment. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Global health status score
Time Frame: At baseline and day 56
|
The Global Health Status will be calculated from the specific subscale included in the EORTC-QLQ-C30 scale. The difference between baseline and the end-point (day 56) will be the primary judgment criteria. A 4 to 8 points difference between baseline and endpoint will be considered as a mild difference, and a difference over 8 points will be considered as a moderate difference. |
At baseline and day 56
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The subjective experience associated with symptoms burden.
Time Frame: At baseline and day 56.
|
Qualitative analysis of compared semi-structured interviews undertaken at baseline and day 56 on a convenience sample.
|
At baseline and day 56.
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Proportion of mitigated symptoms.
Time Frame: Day 28
|
The Edmonton Symptom Assessment Scale 12F will be used to assess each symptoms intensities for the following symptoms: pain, nausea, vomiting, lack of appetite, breathlessness, depression, anxiety, sleep disorders and wellness. For each symptom, the difference between baseline and the assessment time will be calculated. A difference equal or over one point will be regarded as mitigation. The judgment criteria will be the proportion of symptoms that were rated over three at baseline and that were mitigated at the assessment time. |
Day 28
|
Proportion of mitigated symptoms.
Time Frame: Day 56
|
The Edmonton Symptom Assessment Scale 12F will be used to assess each symptoms intensities for the following symptoms: pain, nausea, vomiting, lack of appetite, breathlessness, depression, anxiety, sleep disorders and wellness. For each symptom, the difference between baseline and the assessment time will be calculated. A difference equal or over one point will be regarded as mitigation. The judgment criteria will be the proportion of symptoms that were rated over three at baseline and that were mitigated at the assessment time. |
Day 56
|
Auto-assessment depression score.
Time Frame: Day 28
|
The Hospital Anxiety and Depression Scale-D auto-assessment score will be used to assess the auto-assessment depression score. The judgment criteria will be the difference between baseline and the assessment time. A difference over 1.5 points will be regarded as clinically significant. |
Day 28
|
Auto-assessment depression score.
Time Frame: Day 56
|
The Hospital Anxiety and Depression Scale-D auto-assessment score will be used to assess the auto-assessment depression score. The judgment criteria will be the difference between baseline and the assessment time. A difference over 1.5 points will be regarded as clinically significant. |
Day 56
|
Hetero-assessment-based depression score.
Time Frame: Day 28
|
The Montgomery-Asberg Depression Rating Scale hetero-assessment score will be used to assess the hetero-assessment depression score. The judgment criteria will be the difference between baseline and the assessment time. A difference over 1.9 points will be regarded as clinically significant. |
Day 28
|
Hetero-assessment-based depression score.
Time Frame: Day 56
|
The Montgomery-Asberg Depression Rating Scale hetero-assessment score will be used to assess the hetero-assessment depression score. The judgment criteria will be the difference between baseline and the assessment time. A difference over 1.9 points will be regarded as clinically significant. |
Day 56
|
Weight control
Time Frame: Day 28
|
Weight control will be defined as a difference under 500g between the weight at baseline minus the weight at the assessment time. The judgment criteria will be the proportion of patients with weight control at assessment time. |
Day 28
|
Weight control
Time Frame: Day 56
|
Weight control will be defined as a difference under 500g between the weight at baseline minus the weight at the assessment time. The judgment criteria will be the proportion of patients with weight control at assessment time. |
Day 56
|
Weight improvement.
Time Frame: Day 28
|
Weight improvement will be defined as a difference over 500g between the weight at the assessment time minus the weight at baseline. The judgment criteria will be the proportion of patients with weight improvement at assessment time. |
Day 28
|
Weight improvement.
Time Frame: Day 56
|
Weight improvement will be defined as a difference over 500g between the weight at the assessment time minus the weight at baseline. The judgment criteria will be the proportion of patients with weight improvement at assessment time. |
Day 56
|
Stability in oral morphine milligram equivalents.
Time Frame: Day 28
|
The stability in oral morphine milligrams equivalent will be defined as a decrease or stability in the daily doses of opioid pain killers measured using oral morphine milligram equivalents. The judgment criteria will be the proportion of patients with stability in oral morphine milligram equivalents. |
Day 28
|
Stability in oral morphine milligram equivalents.
Time Frame: Day 56
|
The stability in oral morphine milligrams equivalent will be defined as a decrease or stability in the daily doses of opioid pain killers measured using oral morphine milligram equivalents. The judgment criteria will be the proportion of patients with stability in oral morphine milligram equivalents. |
Day 56
|
Escalation in symptom control treatment doses
Time Frame: Day 28
|
Escalation in symptom control treatment doses will be defined as any escalation in the dose of a treatment existing at baseline or any new treatment introduced to control one of the following symptoms: pain, nausea, vomiting, lack of appetite, breathlessness, depression, anxiety, sleep disorders and wellness. The judgment criteria will be the proportion of patients with an escalation in symptom control treatment doses. |
Day 28
|
Escalation in symptom control treatment doses
Time Frame: Day 56
|
Escalation in symptom control treatment doses will be defined as any escalation in the dose of a treatment existing at baseline or any new treatment introduced to control one of the following symptoms: pain, nausea, vomiting, lack of appetite, breathlessness, depression, anxiety, sleep disorders and wellness. The judgment criteria will be the proportion of patients with an escalation in symptom control treatment doses. |
Day 56
|
Number of side effects.
Time Frame: Day 7
|
The number of side effects will be used to assess the security of use.
It will be assessed using the Antidepressant Side Effect Checklist and side effects will be considered if rated moderate or severe.
|
Day 7
|
Number of side effects.
Time Frame: Day 14
|
The number of side effects will be used to assess the security of use.
It will be assessed using the Antidepressant Side Effect Checklist and side effects will be considered if rated moderate or severe.
|
Day 14
|
Number of side effects.
Time Frame: Day 28
|
The number of side effects will be used to assess the security of use.
It will be assessed using the Antidepressant Side Effect Checklist and side effects will be considered if rated moderate or severe.
|
Day 28
|
Number of side effects.
Time Frame: Day 56
|
The number of side effects will be used to assess the security of use.
It will be assessed using the Antidepressant Side Effect Checklist and side effects will be considered if rated moderate or severe.
|
Day 56
|
Medication adherence.
Time Frame: Day 56
|
The medication adherence will be assessed using the Medication Adherence Rating Scale score at day 56 and the Proportion of Days Covered all along the follow-up period.
|
Day 56
|
Symptoms' intensities auto-assessment on the following symptoms: pain, nausea, vomiting, lack of appetite, breathlessness, depression, anxiety, sleep disorders and wellness.
Time Frame: Day 28
|
The Edmonton Symptom Assessment Scale 12F will be used to assess each symptoms intensities for the following symptoms: pain, nausea, vomiting, lack of appetite, breathlessness, depression, anxiety, sleep disorders and wellness. For each symptom, the difference between baseline and the assessment time will be used as the judgment criteria. A difference equal or over one point will be regarded as clinically significant. |
Day 28
|
Symptoms' intensities auto-assessment on the following symptoms: pain, nausea, vomiting, lack of appetite, breathlessness, depression, anxiety, sleep disorders and wellness.
Time Frame: Day 56
|
The Edmonton Symptom Assessment Scale 12F will be used to assess each symptoms intensities for the following symptoms: pain, nausea, vomiting, lack of appetite, breathlessness, depression, anxiety, sleep disorders and wellness. For each symptom, the difference between baseline and the assessment time will be used as the judgment criteria. A difference equal or over one point will be regarded as clinically significant. |
Day 56
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Guillaume ECONOMOS, MD, Centre Hospitalier Lyon Sud - Service de Soins Palliatifs
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplastic Processes
- Neoplasms
- Neoplasm Metastasis
- Physiological Effects of Drugs
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Tranquilizing Agents
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Serotonin 5-HT2 Receptor Antagonists
- Serotonin Antagonists
- Anti-Anxiety Agents
- Serotonin 5-HT3 Receptor Antagonists
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Adrenergic alpha-Antagonists
- Adrenergic alpha-2 Receptor Antagonists
- Selective Serotonin Reuptake Inhibitors
- Mirtazapine
- Escitalopram
Other Study ID Numbers
- 69HCL20_0032
- 2020-002994-90 (EudraCT Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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