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Life sciences · Phase 2/3 Trial
ClinicalTrials.gov · November 9, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 2/3 Trial.
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Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT06891300). This is a study registration, not published results. Lead sponsor: The Royal's Institute of Mental Health Research. Recruitment status: RECRUITING. Phase: PHASE2, PHASE3. Study type: INTERVENTIONAL. Enrollment: 36 participants (ESTIMATED). Conditions: Suicidal Ideation, Major Depressive Disorder (MDD). Interventions: DRUG: ketamine hydrochloride. Primary outcome measures: Change in white matter microstructure from pre-treatment to post-treatment, assessed via MRI. , Pre-treatment (up to -48 hours) to post-treatment (24+/-6 hours). Brief summary: The goal of this clinical trial is to treat active suicidal ideation in individuals with Major Depressive Disorder (MDD) using ketamine and to understand suicidal ideation by examining biological mechanisms using magnetic resonance imaging (MRI), and psychological mechanisms through validated clinical scales and qualitative interviews. The main questions it aims to answer are: 1. Will ketamine will reduce suicidal ideation in a significant proportion of study participants? 2. Will reduction in suicidal ideation will be accompanied by rapid changes in neuroimaging biomarkers? Participants will receive four intravenous (IV) ketamine infusions administered twice weekly for two weeks. Participants will undergo two identical MRI scans: 1) within 48 hours prior to starting ketamine treatment, and 2) 24 hours after the fourth ketamine infusion. Suicidal ideation and depressive symptoms will be assessed prior to each imaging session alongside additional self-report measures. Qualitative interviews will occur within 72 hours after the fourth ketamine treatment.