Resistant Depression in the Elderly Subject
Conditions
Interventions
Trade Name: KALINOX® (MEOPA)
Pharmaceutical Form: Medicinal gas, compressed
Pharmaceutical form of the placebo: Medicinal gas, compressed
Route of administration of the placebo: Inhalation use
Sponsors
CHRU TOURS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Between 60 and 90 years old. - Diagnosis of depressive episode characterized according to DSM-5 criteria, confirmed by the Mini International Neuropsychiatric Interview (MINI). - Depression score on the MADRS scale greater than 20 (Montgomery Asberg Depression Rating Scale). - Patients resistant to at least one well-conducted antidepressant for the current depressive episode as assessed by the MGH-ATRQ scale. - Patients who can be subjected to the delivery of MOEPA via a facial mask. - A person who has signed an informed consent form. - Person affiliated with a social security or other regime Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: - Bipolar disorder, schizophrenic, neurodegenerative disease documented by MINI and MMSE (non-inclusion if MMSE< 24/30), addiction to one or more toxic substances. - Unstable somatic pathology (particularly unstable neurological or cardiological pathologies at risk of interfering with the diffusion of MEOPA) - Presence of active and significant psychotic symptoms, at the discretion of the investigator - Contraindications to the use of MEOPA: pneumothorax, emphysema, intestinal occlusion, intracranial hypertension, known and unsubstituted vitamin B12 or B9 deficiency. - MRI contraindications, especially claustrophobia. - Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, purpose or consequences of the study. - A person participating in a clinical drug study or in a period of exclusion from any clinical study due to previous participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare changes in depressive symptomatology at 2 hours, 24 hours, Week 1 and Week 2 of exposure to MEOPA versus medical air, in a population of elderly subjects with a characterized depressive episode meeting the criteria for resistant depression and treated with antidepressants.;Secondary Objective: 1. To compare the dynamics of changes in Tissue Pulsatility Imaging (TPI) during diffusion of the gaseous product between responder (MADRS decrease > 50%), non-responder (MADRS decrease < 50%) and comparator patients. 2. To compare structural (brain volume, brain leukopathy) and functional (ASL infusion, BOLD Pulsatility and Brain Connectivity) MRI data between responder, non-responder and comparator patients at baseline. 3. To compare changes in depressive symptomatology between subjects in the MEOPA group vs. comparator group, as measured by the Hamilton Scales for Depressive Symptom Intensity, CGI for Clinical Global Impression, and QIDS-SR for Self-Rated Mood. 4. To compare tolerance between subjects in the MEOPA group vs. comparator group, as measured by the SSI scale for suicidal ideation, YMRS for manic symptoms, CADSS and BPRS for dissociative symptoms.;Primary end point(s): MADRS Depression Severity Scale collected in the MEOPA group vs. comparator;Timepoint(s) of evaluation of this end point: At baseline, 2 hours, 24 hours, Week 1 and Week 2 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Brain Pulsatility Indices as measured by IPT Ultrasound Imaging 2. Brain volume and white matter lesion indices measured by MRI, indicators of brain atrophy and lesion load; Brain perfusion indices measured by MRI-ASL; Pulsatilité´ and Brain Connectivity indices as measured by MRI in BOLD signal 3. A series of scales complementary to the MADRS for the evolution of depressive symptoms (Hamilton 17-items, CGI - Clinical Global Impression, QIDS-SR - Quick Inventory of Depressive Symptomatology Self Report). 4. A series of scales for the evaluation of possible adverse effects (SSI - Scale for Suicidal Ideation, YMRS - Young Mania Rating Scale, CADSS - Clinician Administered Dissociative States Scale, BPRS - Brief Psychiatric Rating Scale).;Timepoint(s) of evaluation of this end point: 1. At baseline 2. At baseline 3. At baseline, 2 hours, 24 hours, Week 1 and Week 2 4. At baseline, 2 hours, 24 hours, Week 1 and Week 2 | — |
Countries
France
Contacts
Public ContactARC DRCI - Estelle BOIVIN
CHRU TOURS
Outcome results
None listed