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Ketamine Trial for Acute suicidality - pilot

Conditions
Acute Suicidality
Registration Number
NL-OMON20015
Lead Sponsor
niversity Medical Center Groningen (UMCG)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
12
Inclusion Criteria

Acute suicidality: suicidal thoughts and/or behaviour have increased within the last 24 hours.
BSSI score = 7
Subjects are in the age of 18-70

Exclusion Criteria

Earlier participation in this study
Psychosis (as a primary diagnosis) (depression with psychotic features will not be an exclusion criterion per se).
Schizophrenia or another primary psychotic disorder
History of PCP- or ketamine addiction
Being under influence of GHB (Substance abuse in the (recent) history is not an exclusion criterion per se (with the exception of current GHB-intoxication and a high blood alcohol concentration, and intoxications leading to medical unstable conditions). Use of GHB will be assessed by asking the participant, since urinary analysis is relatively unreliable, and waiting for results of the blood test will, given the acute nature of this study, be too time consuming.
A blood alcohol concentration (BAC) of > 0.05%
Clinically significant and unstable infectious, immunological, neurological cardiovascular, gastro-intestinal, pulmonary, renal, ophthalmological (glaucoma), hepatic, endocrine or haematological disorder, a myocardial infarction, micturition problems or a complex surgical problem that needs immediate attention.
Presence of any contra-indication for ketamine use, such as severe high blood pressure, a recent myocardial infarction or relevant cardiac problems, severe thyroid problems, severe liver problems, severe kidney problems, epilepsy and increased intracranial pressure.
A known hypersensitivity for ketamine
Concomitant use of a MAO-inhibitor
Severe nose congestion or nasal polyps
Pregnancy or giving breastfeeding
Women in the reproductive age using unreliable contraception
Being unable to answer the questionnaires
Legal incompetency with regard to participation in this study
No informed consent

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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