Actively Recruiting
Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response
Led by Yale University · Updated on 2026-05-06
50
Participants Needed
1
Research Sites
481 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The proposed study will assess the combined effect of perampanel and ketamine on the anti-depressant response in individuals with treatment resistant depression. The purpose of this study is to test the hypothesis that stimulation of Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid receptors (AMPAR) is critical to the anti-depressant response of ketamine.
CONDITIONS
Official Title
Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Right-handed as determined by the Edinburgh Handedness Inventory
- Current depression indicated by a score greater than 17 on the Hamilton Depression Rating Scale
- History of failure of one or more adequate anti-depressant trials
- Previous positive response to ketamine treatment if previously received
- Meets DSM-5 criteria for Major Depressive Disorder as determined by SCID-5
- Engaged in treatment outside the research protocol or willing to be referred
- Receiving pharmacotherapy for depression at stable dose for at least 4 weeks with plan to continue during trial
- Receiving psychotherapy for at least 4 weeks with plan to continue during trial
- Willing to refrain from caffeine, drug, and alcohol use for one week prior to each MRI session
- Females must not be pregnant or breastfeeding and agree to use medically accepted birth control or be surgically sterile/post-menopausal
- Females will receive ketamine during the follicular phase of menstrual cycle when possible
- Able to read and write English
- Have at least a 12th grade education level or equivalent
You will not qualify if you...
- High risk for suicide with intent or plan as assessed by Columbia Suicide Severity Rating Scale or investigators
- Neurological disorders excluding migraines or more than mild head injury
- Current therapeutic treatment with ketamine
- Treatment with topiramate, memantine, or barbiturates within two weeks of randomization
- Daytime use of benzodiazepines
- Treatment with monoamine oxidase inhibitors within 4 weeks of randomization
- Treatment with vagal nerve stimulator, ECT, or deep brain stimulation within two weeks of randomization
- Psychosis except mood-congruent psychotic experiences during depression
- Insulin-dependent or poorly controlled non-insulin dependent diabetes
- Other major medical disorders unless cleared by study physician
- History of violence unless cleared by investigators
- Substance or alcohol use disorder within three months prior to screening except mild alcohol use disorder at investigator discretion
- Positive screening urine drug or breathalyzer tests
- Clinically significant abnormalities on ECG or laboratory exams unless cleared by physician
- History of positive HIV or Hepatitis B
- Use of centrally active medicine or herbal supplements within one week prior to MRI unless deemed safe
- Known sensitivity to ketamine or heparin
- Unstable blood pressure or heart rate unless cleared by study physician
- History of intellectual disability
- History of claustrophobia
- Significant impairment of color vision or visual acuity after correction
- Presence of pacemaker, electronic device, or ferromagnetic metal foreign bodies incompatible with MRI
- Advised not to drive or operate heavy machinery for 24 hours after infusion
- Blood donation exceeding 500 mL within 56 days prior to dosing or similar blood loss
- Other exclusions at discretion of investigators
AI-Screening
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Trial Site Locations
Total: 1 location
1
Yale University
New Haven, Connecticut, United States, 06511
Actively Recruiting
Research Team
N
Naomi Driesen, Ph.D.
CONTACT
E
Elizabeth Traester, B.A.
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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