Actively Recruiting

Phase 2
Phase 3
Age: 18Years - 65Years
All Genders
NCT06891300

Understanding and Treating Suicidal Ideation With Ketamine

Led by The Royal's Institute of Mental Health Research · Updated on 2025-04-11

36

Participants Needed

1

Research Sites

77 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Official Title

Understanding and Treating Suicidal Ideation With Ketamine

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • English speaking
  • Ages 18-65 years old
  • Suicidal ideation severity score 653 on the Columbia Suicide Severity Rating Scale (C-SSRS) at Screening Visit ("active suicidal ideation with any methods")
  • Diagnosis of Major Depressive Disorder (MDD) according to DSM-5
  • Willing to maintain stable doses of concomitant medications throughout the study
  • Under care of a designated health care provider to follow care after study completion
Not Eligible

You will not qualify if you...

  • Not medically cleared for ketamine due to 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) 6535
  • History of primary psychotic disorder or recent acute psychosis episode (<2 years)
  • Current or recent ( <12 months) substance use/dependence or problematic alcohol use (except caffeine or nicotine)
  • Pregnant, breastfeeding, or of childbearing potential and unwilling to use approved contraception
  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Royal Ottawa Mental Health Centre

Ottawa, Ontario, Canada, K1Z7K4

Actively Recruiting

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Research Team

R

Research Coordinator

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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