Understanding and Treating Suicidal Ideation With Ketamine
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorThe Royal's Institute of Mental Health Research
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
ketamine hydrochloride
DrugParticipants 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.
Treatment groups
36 Participants
are divided into 1 treatment groupGroup A: KetamineExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Pre-treatment (up to -48 hours) to post-treatment (24+/-6 hours)Secondary outcomes
1
Change in extracellular free water from pre-treatment to post-treatment, assessed via MRI.
Change in extracellular free water pre-post repeated ketamine infusions.
Time frame
Pre-treatment (up to -48 hours) to post-treatment (24+/-6 hours)2
Change in neurite density index from pre-treatment to post-treatment, assessed via MRI.
Change in neurite density index pre-post repeated ketamine infusions.
Time frame
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).
Change in suicidal ideation from pre-treatment to post-treatment, as measured by the Beck Suicide Scale (BSS). The total BSS score can range from 0 to 38, with higher values indicating greater suicidal ideation severity.
Time frame
Pre-treatment (up to -48 hours) to post-treatment (24+/-6 hours)Sponsors and contacts
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Source ClinicalTrials.gov