Cerebrovascular reaction to nitrous oxide in Resistant Depression: Pilot study (PROTO-BRAIN) - PROTO-BRAIN pilot

CHRU DE TOURS0 个研究点目标入组 30 人开始时间: 2019年7月15日最近更新: 2019年12月16日

试验速览

暂无简介。

•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

•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.

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