NCT06891300RecruitingPhase 2/3
Understanding and Treating Suicidal Ideation With Ketamine
Understanding and Treating Suicidal Ideation With Ketamine: A Diffusion Magnetic Resonance Imaging Study
Source: ClinicalTrials.gov · Last updated 19 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 12 Mar 2025
- Start date
- 8 Apr 2025
- Primary completion date
- Oct 2026
- Lead sponsor
- The Royal's Institute of Mental Health Research
- Diseases
- Depression
- NCT number
- NCT06891300
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 36
- From 8 Apr 2025 to the primary completion date, Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent use of ketamine in any form
- Concurrent active ECT or repetitive transcranial magnetic stimulation (rTMS) therapy
Other illness
- 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).
- Known or suspected hypersensitivity or intolerance to ketamine
- History of significant head injury including loss of consciousness \>5 minutes
Age
- History of a primary psychotic disorder (e.g., schizophrenia), or current or recent (\<2 years) acute episode of psychosis
Other
- Body mass index (BMI) ≥35
- 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
- Pregnant, breastfeeding or of childbearing potential and unwilling to use an approved method of contraception during the study
- Any MRI contraindications
Who the study is looking for
- English speaking
- Ages 18-65 years old
- 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")
- Diagnosis of Major Depressive Disorder (MDD) according to the Diagnostic and Statistical Manual for Mental Disorders 5th Edition (DSM-5)
- Willing to maintain stable doses of concomitant medications throughout the study
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Ottawa Mental Health Centre Coordinator of this site? Confirm its status | Ottawa | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.