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โ† Trials
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Understanding and Treating Suicidal Ideation With Ketamine

RecruitingPhase 2, Phase 3Ages 18 Years - 65 YearsAllThe Royal's Institute of Mental Health Research
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In plain words

What the trial is, and whether it could suit you

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 b

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. English speaking 2. Ages 18-65 years old 3. Suicidal ideation severity score โ‰ฅ3 on the Columbia Suicide Severity Rating Scale (C-SSRS) (Baseline/Screening version) at Screening Visit ("active suicidal ideation with any methods") 4. Diagnosis of Major Depressive Disorder (MDD) according to the Diagnostic and Statistical Manual for Mental Disorders 5th Edition (DSM-5) 5. Willing to maintain stable doses of concomitant medications throughout the study 6. 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. Exclusion Criteria: 1. 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). 2. Known or suspected hypersensitivity or intolerance to ketamine 3. Body mass index (BMI) โ‰ฅ35 4. History of a primary psychotic disorder (e.g., schizophrenia), or current or recent (\<2 years) acute episode of psychosis 5. 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 6. Pregnant, breastfeeding or of childbearing potential and unwilling to use an approved method of contraception during the study 7. History of significant head injury including loss of consciousness \>5 minutes 8. Any MRI contraindications 9. Concurrent use of ketamine in any form 10. Concurrent active ECT or repetitive transcranial magnetic stimulation (rTMS) therapy
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What it tests

  • ketamine hydrochloride
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Where

1 site
Royal Ottawa Mental Health Centre
Ottawa, Canada
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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