Understanding and Treating Suicidal Ideation With Ketamine

NCT06891300 | Recruiting Phase 2 DMC

• 2 other identifiers: REB 0216ECR-1-119-23
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Will ketamine will reduce suicidal ideation in a significant proportion of study participants?
2. 2.Will reduction in suicidal ideation will be accompanied by rapid changes in neuroimaging biomarkers?

Conditions

Suicidal Ideation; Major Depressive Disorder (MDD)

Keywords

Major Depressive Disorder; Suicidal Ideation; Ketamine; Neuroimaging

Outcome Measures

Primary Outcomes (1)

• Change in white matter microstructure from pre-treatment to post-treatment, assessed via MRI.

  Change in white matter microstructure (free water corrected fractional anisotropy) from pre-treatment to 24 hours post-treatment.

  Pre-treatment (up to -48 hours) to post-treatment (24+/-6 hours)

Secondary Outcomes (2)

• Change in extracellular free water from pre-treatment to post-treatment, assessed via MRI.

  Pre-treatment (up to -48 hours) to post-treatment (24+/-6 hours)

• Change in neurite density index from pre-treatment to post-treatment, assessed via MRI.

  Pre-treatment (up to -48 hours) to post-treatment (24+/-6 hours)

Other Outcomes (1)

• Change in suicidal ideation from pre-treatment to post-treatment, assessed via the Beck Suicide Scale (BSS).

  Pre-treatment (up to -48 hours) to post-treatment (24+/-6 hours)

Study Arms (1)

Ketamine

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.

Drug: ketamine hydrochloride

Interventions

ketamine hydrochloride DRUG

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

Ketamine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Willing to maintain stable doses of concomitant medications throughout the study
• 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.

You may not qualify if:

• 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
• 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
• Pregnant, breastfeeding or of childbearing potential and unwilling to use an approved method of contraception during the study
• 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

Sponsors & Collaborators

• The Royal's Institute of Mental Health Research: lead

Study Sites (1)

Royal Ottawa Mental Health Centre

Ottawa, Ontario, K1Z7K4, Canada

RECRUITING

MeSH Terms

Conditions

Suicidal Ideation; Depressive Disorder, Major

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Jennifer Phillips, PhD

  University of Ottawa Institute for Mental Health Research at The Royal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Coordinator

CONTACT

613-722-6521; suzannah.wojcik@theroyal.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Interim Scientific Director and Scientist

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 24, 2025
• Study Start: April 8, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)