Understanding and Treating Suicidal Ideation With Ketamine
Recruiting · NCT06891300 · Interventional (participants receive a specific treatment) · Lead sponsor: The Royal's Institute of Mental Health Research
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- 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
- Body mass index (BMI) ≥35
- History of a primary psychotic disorder (e.g., schizophrenia), or current or recent (\<2 years) acute episode of psychosis
- 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
- History of significant head injury including loss of consciousness \>5 minutes
- Any MRI contraindications
- Concurrent use of ketamine in any form
- Concurrent active ECT or repetitive transcranial magnetic stimulation (rTMS) therapy
Where it is running
1 location listed.
- Royal Ottawa Mental Health Centre - Ottawa, Ontario, Canada