Nitrous Oxide ("Laughing Gas") for the Treatment of Suicidal Thoughts
Résumé de l'étude
The NITOS study investigates whether inhalation of nitrous oxide (N2O) can reduce suicidal thoughts. Inpatients at the Psychiatric University Hospital Zurich (PUK) who report relevant suicidal thoughts can participate in this double-blind study. They will receive inhalation on Day 1 and Day 8 for approximately 45 minutes each time. However, they will not know whether they are receiving a placebo (oxygen/air) or nitrous oxide (N2O with oxygen). All patients will receive N2O at least once during the two sessions. The severity of suicidality will be documented one day before and after inhalation, using both self-ratings and observer ratings. Additionally, blood samples, electrocardiograms (ECGs), and electroencephalograms (EEGs) will be conducted.
(BASEC)
Intervention étudiée
N2O treatment: Inhalation of nitrous oxide (N2O) for approximately 45 minutes at a concentration of 50%. The N2O will be slowly titrated to 50% over several minutes during the treatment. The N2O will be mixed with oxygen and inhaled through a (nasal) mask. After the N2O treatment, the study participant will receive pure oxygen for about 3 to 5 minutes. The control treatment lasts as long as the N2O treatment and consists of 50% oxygen with air. After the treatment, the study participant will also receive pure oxygen for about 3 to 5 minutes.
(BASEC)
Maladie en cours d'investigation
Mental and behavioral disorders associated with suicidal thoughts/suicidality
(BASEC)
1) Inpatient psychiatric patients aged 18-65 years; 2) Ability to provide written informed consent after being informed; 3) Moderate to severe suicidal thoughts/suicidality, defined as a score ≥3 on the MADRS suicide item (Item #10) and a self-assessment on the Beck Scale for Suicidal Ideation (BSS) items #4 plus #5 with a score ≥ 2. (BASEC)
Critères d'exclusion
F00-F09: Organic, including symptomatic, mental disorders (lifetime diagnosis) F10-F19: Mental and behavioral disorders due to the use of psychoactive substances (see details in the protocol template) F20-F29: Schizophrenia, schizotypal, and delusional disorders (lifetime diagnosis) Non-medical (i.e., recreational) use of inhaled N2O in the last 12 months Previous intolerance or hypersensitivity to N2O Critical illness Severe heart disease Pregnancy or breastfeeding Pulmonary hypertension Chronic cobalamin or folate deficiency Treatment with ketamine/esketamine within the last 4 weeks Recent (within the last 4 weeks) or current use of benzodiazepines exceeding 5 mg of lorazepam or equivalent per day Electroconvulsive therapy (ECT) within the last 3 months (BASEC)
Lieu de l’étude
Zurich
(BASEC)
Sponsor
Professor Dr. med. Sebastian Olbrich
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Professor Dr. med. Sebastian Olbrich
+41 58 384 26 37
sebastian.olbrich@clutterpukzh.chPsychiatrische Universitätsklinik Zürich
(BASEC)
Informations scientifiques
non disponible
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale de Zurich
(BASEC)
Date d'approbation du comité d'éthique
06.08.2024
(BASEC)
Identifiant de l'essai ICTRP
non disponible
Titre officiel (approuvé par le comité d'éthique)
Nitrous Oxide in the Treatment of Acute Suicidal Ideation (BASEC)
Titre académique
non disponible
Titre public
non disponible
Maladie en cours d'investigation
non disponible
Intervention étudiée
non disponible
Type d'essai
non disponible
Plan de l'étude
non disponible
Critères d'inclusion/exclusion
non disponible
non disponible
Critères d'évaluation principaux et secondaires
non disponible
non disponible
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
non disponible
Contacts supplémentaires
non disponible
ID secondaires
non disponible
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
non disponible
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible