About this trial
This study explores how stress, suicidal thoughts, and ketamine's effects are connected in people with major depressive disorder. Stress increases the risk for suicidal thoughts, but the biological basis is unclear. Ketamine may help reduce suicidal thoughts by affecting stress-linked brain systems. This study will use smartphone tracking to monitor real-time responses to stress and positron emission tomography (PET) brain scans to study how ketamine affects brain pathways related to stress and suicidal thoughts in depressed individuals.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
DSM5 unipolar major depressive episode
Persons of child-bearing potential must agree to use an acceptable method of birth control throughout the study.
Disqualifiers
Current or past ketamine abuse or dependence ever (lifetime)
Any medical contraindication to ketamine, including prior ineffective trial of or medically significant adverse reaction to ketamine.
Clinically significant EKG abnormality in terms of ketamine administration (e.g., Ventricular tachycardia, evidence of myocardial ischemia, symptomatic bradycardia, unstable tachycardia, second degree (or greater) AV block).
Lifetime schizophrenia, schizoaffective illness, bipolar disorder, current psychotic depression; mild drug or alcohol use disorder in past 2 months; moderate or severe drug or alcohol use disorder in past 6 months; suicidal ideation with plan and/or intent within 6 months; suicide attempt in the past month.
Trial design
Single group
Treatments tested in this trial
Ketamine hydrochloride infusion
Drugsingle racemic ketamine hydrochloride 0.5 mg/kg infusion
Treatment groups
Trial outcomes
Primary outcomes
Scale for Suicidal Ideation (SSI)
Beck Scale for Suicidal Ideation clinician-rated version. Minimum score = 0, Maximum score = 38. Higher scores mean a worse outcome.
Sponsors and contacts
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New York State Psychiatric Institute
Lead sponsor
American Foundation for Suicide Prevention
Collaborator
This trial is not recruiting at the moment. You can still explore other options: