Nitrous Oxide ("Laughing Gas") for the Treatment of Suicidal Thoughts
Zusammenfassung der Studie
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)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
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)
Studienstandort
Zürich
(BASEC)
Sponsor
Professor Dr. med. Sebastian Olbrich
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Professor Dr. med. Sebastian Olbrich
+41 58 384 26 37
sebastian.olbrich@clutterpukzh.chPsychiatrische Universitätsklinik Zürich
(BASEC)
Wissenschaftliche Auskünfte
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Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
06.08.2024
(BASEC)
ICTRP Studien-ID
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Offizieller Titel (Genehmigt von der Ethikkommission)
Nitrous Oxide in the Treatment of Acute Suicidal Ideation (BASEC)
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Untersuchte Krankheit(en)
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Untersuchte Intervention
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