Safety outcomes
mood deterioration, ideation, wrist injury, auditory hallucination, deaths
ADVERSE EVENTS, SIDE EFFECT, ADVERSE EVENT, EVENTS, EVENTS
Serious adverse events were rare and most were unrelated to the study drug: in cohort 1 there were two in the midazolam group (suicide attempt (unrelated) and mood deterioration (unrelated) and none in the ketamine group; in cohort 2 there were three in the midazolam group (suicide attempt (unrelated), increased suicidal ideation (unrelated) and wrist injury (unrelated)) and two in the ketamine group (major dissociative episode (related) and auditory hallucination (related)). There were no deaths reported throughout the study. Four ketamine participants (Acute post-treatment adverse events (over the first 60 min post dosing)Adverse events were evaluated using the Clinician-Administered Dissociative States Scale (CADSS), the Young Mania Rating Scale (YMRS) and Section B of the Ketamine Side Effect Tool (KSET). Section B of the KSET reflects symptoms observed at any time in the 60 min following a ketamine or midazolam injection. The incidence of participants experiencing each adverse event was compared between ketamine and midazolam groups using a Fisher's exact test. Events are reported in order from highest to lowest frequency across all participants.This includes subjective reports of dissociation as well as the number of participants with a >4-point increase in the CADSS total score from baseline.Euphoria was operationalised as the number of participants with a score of ≥4 on item 1 of the YMRS.