Oral Ketamine Trial on Suicidality

Phase 2

Completed

• Conditions: Chronic suicidality; Mental Health - Suicide

• Registration Number: ACTRN12618001412224
• Lead Sponsor: Sunshine Coast Mind and Neuroscience - Thompson Institute, University of the Sunshine Coast

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-23
• Study Completion: 2019-10-16
• Last Update Posted: 1 February 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients with chronic suicidal thoughts as the primary presenting complaint, determined by a score of greater than or equal to 6 for the Scale for Suicide Ideation (BSS)
• Persons (male/female/other) aged over 18 years
• Participant to receive physical examination from Principal Investigator within 14 days prior to commencement of ketamine treatment to eliminate possibility of conditions outlined in
exclusion criteria
• Participants must be able to understand the PIF and provide written informed consent on the Participant Consent Form (PCF)

Exclusion Criteria

• Persons under 18 years of age
• Psychosis
• Mania/hypomania
• Acute suicidality requiring urgent psychiatric intervention
• Uncontrolled/severe symptomatic cardiovascular disease states including: recent myocardial infarction (within prior 6 months); history of stroke; and hypertension (resting blood pressure >150/100)
• History of intracranial mass, intracranial haemorrhage/stroke, cerebral trauma/traumatic brain injury or increased intracranial pressure (as assessed by referring general practitioner)
• Liver function test (LFT) results that exceed the upper level of normal range by 3 times
• Previous reaction to ketamine (as reported by referring general practitioner and participant)
• Pregnant women
• Breastfeeding women

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To examine and explore the effectiveness of oral ketamine, an NMDA (N-methyl-D-aspartate) receptor antagonist, in patients who are experiencing chronic suicidal ideation.<br>Change in suicidality will be assessed using the Beck Scale for Suicide Ideation (BSS). Any reduction in suicidality as determined by this scale is the primary outcome measure of this study.[Suicidality will initially be assessed at baseline, and then at four time points per week during the treatment phase (week 1 to 6). The four time points are: 1) on treatments days pre-ketamine, 2) on treatments days post-ketamine, 3) one day post-ketamine, and 4) three days post-ketamine. Suicidality will then be assessed in the follow up phase once at Week 10.]