NCT06891300 Understanding and Treating Suicidal Ideation With Ketamine
| NCT ID | NCT06891300 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | The Royal's Institute of Mental Health Research |
| Condition | Suicidal Ideation |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2025-04-08 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 36 participants in total. It began in 2025-04-08 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. English speaking 2. Ages 18-65 years old 3. Suicidal ideation severity score ≥3 on the Columbia Suicide Severity Rating Scale (C-SSRS) (Baseline/Screening version) at Screening Visit ("active suicidal ideation with any methods") 4. Diagnosis of Major Depressive Disorder (MDD) according to the Diagnostic and Statistical Manual for Mental Disorders 5th Edition (DSM-5) 5. Willing to maintain stable doses of concomitant medications throughout the study 6. Be under the care of a designated health care provider (i.e., family physician or psychiatrist) to follow their care after the completion of the study. Exclusion Criteria: 1. Participants not medically cleared to receive ketamine treatment due to presence of clinically relevant disease (e.g., uncontrolled hypertension, renal or hepatic impairment, significant coronary artery disease, diabetes mellitus, seizure disorder). 2. Known or suspected hypersensitivity or intolerance to ketamine 3. Body mass index (BMI) ≥35 4. History of a primary psychotic disorder (e.g., schizophrenia), or current or recent (\<2 years) acute episode of psychosis 5. Current and/or recent history (\<12 months) of substance use/dependence (except for caffeine or nicotine) or problematic current alcohol use or dependence as defined by DSM-5 criteria 6. Pregnant, breastfeeding or of childbearing potential and unwilling to use an approved method of contraception during the study 7. History of significant head injury including loss of consciousness \>5 minutes 8. Any MRI contraindications 9. Concurrent use of ketamine in any form 10. Concurrent active ECT or repetitive transcranial magnetic stimulation (rTMS) therapy
Contact & Investigator
Jennifer Phillips, PhD
PRINCIPAL INVESTIGATOR
University of Ottawa Institute for Mental Health Research at The Royal
Frequently Asked Questions
Who can join the NCT06891300 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Suicidal Ideation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06891300 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06891300 currently recruiting?
Yes, NCT06891300 is actively recruiting participants. Contact the research team at suzannah.wojcik@theroyal.ca for enrollment information.
Where is the NCT06891300 trial being conducted?
This trial is being conducted at Ottawa, Canada.
Who is sponsoring the NCT06891300 clinical trial?
NCT06891300 is sponsored by The Royal's Institute of Mental Health Research. The principal investigator is Jennifer Phillips, PhD at University of Ottawa Institute for Mental Health Research at The Royal. The trial plans to enroll 36 participants.