Treating suicidal thoughts in depression with ketamine
Understanding and Treating Suicidal Ideation With Ketamine: A Diffusion Magnetic Resonance Imaging Study
This study is testing if ketamine can help people with major depression who are having suicidal thoughts feel better by giving them infusions over two weeks while also looking at their brain activity and experiences.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | The Royal's Institute of Mental Health Research Academic / other |
| Locations | 1 site (Ottawa, Ontario) |
| Trial ID | NCT06891300 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to treat individuals with Major Depressive Disorder (MDD) who are experiencing active suicidal ideation using ketamine. Participants will receive four intravenous ketamine infusions over two weeks while undergoing neuroimaging and psychological assessments to understand the biological and psychological mechanisms of suicidal thoughts. The study will evaluate the effectiveness of ketamine in reducing suicidal ideation and explore changes in brain activity associated with these effects. Additionally, qualitative interviews will provide insights into participants' experiences and thought patterns during treatment.
Who should consider this trial
Good fit: Ideal candidates are English-speaking adults aged 18-65 with a diagnosis of Major Depressive Disorder and active suicidal ideation.
Not a fit: Patients with significant medical conditions that prevent them from receiving ketamine treatment or those with a BMI of 30 or higher may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide rapid relief from suicidal thoughts for patients with Major Depressive Disorder.
How similar studies have performed: Previous studies have shown promising results using ketamine for treating suicidal ideation, indicating that this approach is supported by emerging evidence.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ottawa, Ontario
- Royal Ottawa Mental Health Centre — Ottawa, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Jennifer Phillips, PhD — University of Ottawa Institute for Mental Health Research at The Royal
- Study coordinator: Research Coordinator
- Email: suzannah.wojcik@theroyal.ca
- Phone: 613-722-6521
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.