Resistant Depression - Nervous Breakdown
Conditions
Interventions
Trade Name: KALINOX®
Pharmaceutical Form: Medicinal gas, compressed
Sponsors
CHRU DE TOURS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria common to all participants o Female between 25 and 50 years of age. o A person who can undergo N2O diffusion via a facial mask. o A person who has signed an informed consent. o Person affiliated with a social security scheme. Inclusion Criteria for Depressive Patients o Depressive episode diagnosis characterized according to DSM-5 criteria, confirmed by the Mini International Neuropsychiatric Interview (MINI). o Patients with an ASRD depression score greater than 20 (Montgomery Asberg Depression Rating Scale). o Patients resistant to at least one well-conducted antidepressant treatment, as documented by the MGH-ATRQ scale. o Absence of: bipolar disorder, schizophrenic disorder, neurodegenerative disease, addiction toAbsence of: bipolar disorder, schizophrenic disorder, neurodegenerative disease, addiction to one or more toxics documented by the MINI. Inclusion criteria for healthy voluntary controls o Absence of: clinically significant psychiatric disorders, depression, bipolar disorder, schizophrenia or neurodegenerative disease, current or past. 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 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: o Unstable somatic pathology (including unstable neurological or cardiological pathologies at risk of interfering with N2O diffusion) o Presence of active and significant psychotic symptoms, at investigator’s discretion o Contraindications to mixture 50%N2O/ 50%O2: intracranial hypertension, altered state of consciousness, head trauma, pneumothorax, emphysema bubbles, abdominal gaseous distension, administration of less than 3 months of ophthalmic gas (SF6, C3F8, C2F6) used in eye surgery, known and unsubstituted deficiency in vitamin B12 or folic acid, recent and unexplained neurological abnormalities. o Contraindications to MRI, including claustrophobia. Female who is pregnant or breastfeeding or able to procreate without an effective contraceptive method o Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, purpose or consequences of the study (including major under legal protection). o A person participating in a drug clinical trial or during a period of exclusion from any clinical study due to previous involvement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Compare measurements of cerebral pulsatility in Ultrasound (Tissue pulsatility Imaging – TPI) before, during and after N2O diffusion, between responders ( decrease of MADRS= 50%), non-responders (decrease of MADRS < 50%) and healthy volunteers.;Secondary Objective: 1. Compare the dynamics of changes before and after exposure to N2O, cerebral pulsatility measured in MRI-BOLD, cerebral infusion measured by MRI-ASL and resting functional connectivity measured by MRI-BOLD between responders, non-responders and healthy volunteers. 2. Compare changes in depressive symptomatology in the depressive group, before and after treatment with N2O, as measured by the Hamilton scales, POMS for rapid mood changes, QIDS-SR for mood self-assessment, CGI, STAI-Y-A, EVA subjective. 3. Assess tolerance in all study participants after N2O treatment, as measured by SSI scales for suicidal ideations, YMRS for manic symptoms, CADSS;Primary end point(s): Cerebral pulsatility indices as measured by TPI ultrasonic imaging;Timepoint(s) of evaluation of this end point: 2 months after LVLS | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Brain pulsatility indices measured by MRI-BOLD; Brain infusion indices measured by MRI-ASL; Brain connectivity indices of 3 neural networks (default mode, cognitive and emotional control network) as measured by the MRI in BOLD signal 2. A series of scales complementary to the MADRS for the evolution of depressive symptoms (Hamilton 17-items, POMS – Profile of Mood State, QIDS-SR – Quick Inventory of depressive Symptomatology Self Report, CGI – Clinical Global Impressions, STAI-Y-A – State-Trait Anxiety Inventory, EVA subjective – Visual Analog Evaluation) 3. A series of scales for assessing potential adverse reactions (SSI – Scale for Suicidal Ideation, YMRS – Young Mania Rating Scale, CADSS – Clinician administered dissociative States, BPRS – Brief Psychiatric Rating Scale ; prise-M). ;Timepoint(s) of evaluation of this end point: maximum of 6 month post the last visit of last subject | — |
Countries
France
Contacts
Public ContactClinical Reasearch Associate
CHRU DE TOURS
Outcome results
None listed