RecruitingPhase 2 / Phase 3interventionalRules rewrite

Phase 2 / Phase 3: testing ketamine hydrochloride for Suicidal Ideation

The goal of this clinical trial is to treat active suicidal ideation in individuals with Major Depressive Disorder (major depression) 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.

Official registry: https://clinicaltrials.gov/study/NCT06891300 · The Royal's Institute of Mental Health Research · enrollment listed as 36

What this phase means

Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are ketamine hydrochloride. The registry lists allocation as na. The goal of this clinical trial is to treat active suicidal ideation in individuals with Major Depressive Disorder (major depression) 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.

They plan to enroll about 36 people at Ottawa. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Understanding and Treating Suicidal Ideation With Ketamine: A Diffusion Magnetic Resonance Imaging Study

Interventions: ketamine hydrochloride

Primary outcome (registry wording): Change in white matter microstructure from pre-treatment to post-treatment, assessed via MRI.

Who it is for (from inclusion criteria)

Ages 18 Years to 65 Years
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 (major depression) 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

Who the registry excludes

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 (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

Public study contact (from the registry)

Research Coordinator

613-722-6521

suzannah.wojcik@theroyal.ca

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

Royal Ottawa Mental Health Centre — Ottawa, Ontario, Canada (recruiting)

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FAQ about this NCT record

Is NCT06891300 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06891300?

Phase 2 / Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06891300?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary