This crossover, subject-blinded, clinical trial (n=0, withdrawn) aimed to correlate changes in brain activity with the reduction in suicidal ideation (SI) in response to a single intramuscular dose of ketamine.
Led by Principal Investigator Matthew Klein from the Icahn School of Medicine at Mount Sinai, the study intended to investigate ketamine’s anti-suicidal properties beyond its antidepressant effects. It will determine whether specific electroencephalogram (EEG) findings are associated with SI’s response to intramuscular ketamine and assess its effectiveness in treating acute SI.
The study commenced in February 2022 and concluded in March 2022, with no participants enrolled. The eligibility criteria include adults aged 18 to 70 with current clinically significant SI and inpatient status at the time of study initiation. Exclusion criteria encompass various conditions such as primary psychotic disorder, pregnancy, substance abuse, and medical issues requiring acute intervention.
The study employs a randomized, crossover design with participants receiving either intramuscular ketamine followed by placebo or vice versa. Primary outcome measures include changes in auditory mismatch negativity (EEG), while secondary outcome measures involve changes in the Montgomery-Asberg Depression Rating Scale (MADRS) #10 (SI).
Trial Details
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