This longitudinal, open-label, dose-ranging clinical trial (n=8) aims to evaluate the effectiveness of oral ketamine in individuals experiencing chronic suicidal ideation.
Conducted by the Sunshine Coast Mind and Neuroscience – Thompson Institute at the University of the Sunshine Coast, Australia, the study involves two phases: OKTOS-E and OKTOS-M. Participants who completed the original OKTOS pilot study are eligible for the extension study. In OKTOS-E, oral ketamine will be administered over a 12-week period, while OKTOS-M extends this to 26 weeks.
The primary outcome measures include changes in suicidality assessed using the Beck Scale for Suicide Ideation (BSS) and the Suicidal Ideation Attributes Scales (SIDAS). Secondary outcomes include exploring the neuropathology of suicidality through MRI and EEG, assessing safety and tolerability, examining changes in brain-derived neurotrophic factor levels and cholesterol levels, and evaluating overall functioning and mental state of participants.
The study is non-randomised, with no control group, and involves participants aged over 18 who have previously completed the OKTOS trial. Recruitment for the trial was completed in January 2020, and no individual participant data will be shared due to privacy concerns.
Trial Details
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