Ketamine for Suicidal Thoughts

Overseen by Jennifer Phillips, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: The Royal's Institute of Mental Health Research

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Jennifer Phillips, PhD

Principal Investigator

University of Ottawa Institute for Mental Health Research at The Royal

Eligibility Criteria

This trial is for individuals with Major Depressive Disorder who are currently experiencing suicidal thoughts. Participants must be eligible for MRI scans and willing to undergo multiple ketamine infusions as well as interviews and assessments.

Inclusion Criteria

Must be English speaking

Suicidal ideation severity score ≥3 on the Columbia Suicide Severity Rating Scale (C-SSRS) at Screening Visit

I have been diagnosed with Major Depressive Disorder.

Exclusion Criteria

History of a primary psychotic disorder or current/recent acute episode of psychosis

Current or recent history of substance use/dependence or problematic alcohol use

History of significant head injury including loss of consciousness >5 minutes

Treatment Details

Interventions

• Ketamine (NMDA Receptor Antagonist)

Trial Overview The study tests if ketamine can reduce suicidal ideation in MDD patients. It involves four IV ketamine treatments over two weeks, with MRIs before the first treatment and after the last one, plus regular mental health assessments.

Participant Groups

Group I: Ketamine Experimental Treatment 1 Intervention

Participants will undergo a total of four IV ketamine infusions (0.5 mg/kg infused over 40 minutes), administered twice weekly for two weeks.

Who Is Running the Clinical Trial?

The Royal's Institute of Mental Health Research

Lead Sponsor

Trials

8

Recruited

1,300+