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Search / Trial NCT06891300

Understanding and Treating Suicidal Ideation With Ketamine

Launched by THE ROYAL'S INSTITUTE OF MENTAL HEALTH RESEARCH · Mar 18, 2025

Trial Information

Current as of April 30, 2025

Recruiting

Keywords

Major Depressive Disorder Suicidal Ideation Ketamine Neuroimaging

ClinConnect Summary

This clinical trial is exploring how effective ketamine, a medication often used for anesthesia, can be in treating people who are experiencing suicidal thoughts due to Major Depressive Disorder (MDD). The researchers want to find out if ketamine can significantly reduce these thoughts and if any changes in brain activity can be seen through MRI scans. Participants will receive four ketamine infusions through an IV over two weeks and will have MRI scans before and after the treatment to measure their mental health.

To join the study, participants need to be between 18 and 65 years old, speak English, and have a certain level of suicidal thoughts as measured by a specific scale. They should also have a diagnosis of MDD and be willing to stick to their current medications throughout the trial. Participants will be closely monitored, and their mood will be assessed before each MRI scan as well as through interviews after their treatment. It’s important to note that individuals with certain health conditions, recent substance use issues, or who are pregnant or breastfeeding may not be eligible. This study is currently looking for participants, so it could be an opportunity for those who meet the criteria and are seeking help.

Gender

ALL

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

About The Royal's Institute Of Mental Health Research

The Royal's Institute of Mental Health Research is a leading clinical trial sponsor dedicated to advancing the understanding and treatment of mental health disorders. Affiliated with The Royal Ottawa Mental Health Centre, the Institute conducts innovative research that bridges clinical practice and scientific inquiry. With a focus on patient-centered approaches, it aims to translate findings into effective interventions, fostering partnerships with academic institutions, healthcare providers, and community organizations. The Institute is committed to promoting mental health through rigorous research, ethical standards, and a collaborative environment that prioritizes the well-being of individuals affected by mental illness.

Locations

Ottawa, Ontario, Canada

Patients applied

0 patients applied

Trial Officials

Jennifer Phillips, PhD

Principal Investigator

University of Ottawa Institute for Mental Health Research at The Royal

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported