Actively Recruiting
The Impact of AMPA Receptor Blockade on Ketamine's Anti-Suicidal Effects
Led by Yale University · Updated on 2026-05-06
30
Participants Needed
1
Research Sites
517 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
A
American Foundation for Suicide Prevention
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to test the hypothesis that the anti-depressant and anti-suicidal effects of the N-methyl-D-aspartate receptor (NMDAR) antagonist Ketamine is critically dependent on stimulation of Alpha-Amino-3-Hydroxy-5-Methyl-4-Isoxazole Propionic Acid receptors (AMPAR).
CONDITIONS
Official Title
The Impact of AMPA Receptor Blockade on Ketamine's Anti-Suicidal Effects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Current depression with a score over 17 on the Hamilton Depression Rating Scale and a major depressive episode confirmed by clinical interview
- Current suicidal ideation with a score of 2 or higher on the Hamilton Depression Rating Scale item about death wishes
- History of inadequate response to one or more antidepressant treatments
- Diagnosis of Major Depressive Disorder, Post Traumatic Stress Disorder, or Bipolar Disorder according to DSM-5
- Engagement in mental health treatment outside the study for at least 4 weeks before admission
- Stable pharmacotherapy for depression for at least 4 weeks before randomization with a plan to continue during the trial
- Stable psychotherapy for at least 4 weeks before randomization with a plan to continue during the trial
- Willingness to avoid caffeine, drugs, and alcohol for one week before each Ketamine infusion
- Females not pregnant or breastfeeding and agreeing to use medically accepted birth control methods if applicable
- Females to receive Ketamine during the follicular phase of their menstrual cycle if possible
- Ability to read and write English
- At least a 12th grade education or equivalent
You will not qualify if you...
- Recent serious suicidal intent or plan within last 3 months or judged at serious suicide risk
- Psychiatric hospitalization or suicide attempt in past two months
- Neurological disorders except migraine or mild head injury; more severe head injuries or multiple mild concussions excluded
- Current therapeutic Ketamine treatment or previous trial without benefit
- Recent use of topiramate, memantine, barbiturates, monoamine oxidase inhibitors, vagal nerve stimulator, ECT, or deep brain stimulation within specified timeframes
- Daytime use of benzodiazepines
- Psychosis outside depressive episodes
- Other major medical disorders unless cleared by physician
- History of violence unless approved by study doctors
- Substance or alcohol use disorder in prior 3 months except mild alcohol use disorder at investigator discretion
- Positive drug or alcohol tests before infusion visits unless cleared by physicians
- Clinically significant ECG abnormalities or abnormal lab results unless cleared by physician
- History of positive HIV or Hepatitis B
- Recent use of centrally active medicines or herbal supplements unless cleared
- Known sensitivity to Ketamine or heparin
- Resting blood pressure or heart rate outside specified ranges unless cleared by physician
- History of intellectual disability
- Recent significant blood donation or loss
- Other exclusions at study physicians' discretion
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
VA Connecticut Healthcare System
West Haven, Connecticut, United States, 06516
Actively Recruiting
Research Team
N
Naomi Driesen, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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