Actively Recruiting

Phase 2
Age: 21Years - 65Years
All Genders
NCT05786066

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

Age: 21Years - 65Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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The Impact of AMPA Receptor Blockade on Ketamine's Anti-Suicidal Effects | DecenTrialz