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

Phase 1

• Conditions: Resistant Depression - Nervous Breakdown; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]

• Registration Number: EUCTR2019-002769-37-FR
• Lead Sponsor: CHRU DE TOURS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-15
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 30

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified