Nitrous Oxide ("Laughing Gas") for the Treatment of Suicidal Thoughts
Descrizione riassuntiva dello studio
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)
Intervento studiato
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)
Malattie studiate
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)
Criteri di esclusione
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)
Luogo dello studio
Zurigo
(BASEC)
Sponsor
Professor Dr. med. Sebastian Olbrich
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Professor Dr. med. Sebastian Olbrich
+41 58 384 26 37
sebastian.olbrich@clutterpukzh.chPsychiatrische Universitätsklinik Zürich
(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione etica Zurigo
(BASEC)
Data di approvazione del comitato etico
06.08.2024
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
Nitrous Oxide in the Treatment of Acute Suicidal Ideation (BASEC)
Titolo accademico
non disponibile
Titolo pubblico
non disponibile
Malattie studiate
non disponibile
Intervento studiato
non disponibile
Tipo di studio
non disponibile
Disegno dello studio
non disponibile
Criteri di inclusione/esclusione
non disponibile
non disponibile
Endpoint primari e secondari
non disponibile
non disponibile
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
non disponibile
ID secondari
non disponibile
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
non disponibile
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile