Recruiting

Ketamine for Suicidal Ideation in Major Depressive Disorder

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

ketamine hydrochloride

Drug
Who is being recruted

Behavior+6

+ Mental Disorders

+ Behavioral Symptoms

From 18 to 65 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2 & 3
Interventional
Study Start: April 2025
See protocol details

Summary

Principal SponsorThe Royal's Institute of Mental Health Research
Study ContactResearch Coordinator
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 8, 2025

Actual date on which the first participant was enrolled.

This study aims to explore the use of ketamine as a treatment for individuals experiencing active suicidal thoughts associated with Major Depressive Disorder (MDD). It investigates how ketamine can quickly reduce suicidal ideation, potentially opening up opportunities for other long-term treatments. The research seeks to understand the changes in brain activity related to these thoughts by using advanced MRI scans. By doing so, it hopes to identify new ways to intervene and prevent suicide, which could significantly improve mental health care and provide new insights into the brain's role in suicidal ideation. Participants in the study will receive four intravenous ketamine treatments over a two-week period. These treatments will be administered at a specialized clinic known for handling similar treatments safely. Two MRI scans will be conducted: one before starting the ketamine treatment and another after the final session, to observe changes in brain markers. Throughout the study, participants will also take part in interviews and assessments to evaluate changes in their suicidal thoughts and overall depressive symptoms. The study will last approximately three weeks for each participant, with plans to enroll 36 participants over 18 months, starting in March 2025. The findings are expected to help shape future research and treatment approaches for suicidal ideation.

Official TitleUnderstanding and Treating Suicidal Ideation With Ketamine: A Diffusion Magnetic Resonance Imaging Study
NCT06891300
Principal SponsorThe Royal's Institute of Mental Health Research
Study ContactResearch Coordinator
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

36 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorMental DisordersBehavioral SymptomsDepressive Disorder, MajorDepressive DisorderSuicideSelf-Injurious BehaviorMood DisordersSuicidal Ideation

Criteria

6 inclusion criteria required to participate
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)
Show More Criteria
10 exclusion criteria prevent from participating
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Royal Ottawa Mental Health Centre

Ottawa, CanadaOpen Royal Ottawa Mental Health Centre in Google Maps
Recruiting
One Study Center
Ketamine for Suicidal Ideation in Major Depressive Disorder | PatLynk