A longitudinal open-label, dose-ranging clinical trial to evaluate the effectiveness of oral ketamine, an NMDA (N-methyl-D-aspartate) receptor antagonist, in patients who are experiencing chronic suicidal ideation

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.

Topic Suicidality
Compound Ketamine
Country Australia
Visit trial
Status Completed
Results Published No
Start date 06 December 2018
End date 04 June 2020
Phase Phase I Phase II
Design Open
Type Interventional
Generation First
Participants 8
Sex All
Age 18- 99
Therapy No

Trial Details

This longitudinal study is an extension of the Oral Ketamine Trial on Suicidality. This study is an open-label, dose-ranging clinical trial of oral ketamine. Treatment will involve administration of oral ketamine over a 12-week period for Phase 1 (OKTOS-E) and over 26 weeks for Phase 2 (OKTOS-M). The pathology and neurobiology of suicidality will be examined via MRI and EEG as neurological measures. The primary outcome of change in suicidality will be assessed using the Beck Scale for Suicide Ideation (BSS) and the Suicidal Ideation Attributes Scales (SIDAS) as a composite outcome

NCT Number ACTRN12618001937202

Data attribution

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