Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT05915013
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Ketamine — DRUG
    Intravenous ketamine
  • Perampanel — DRUG
    Oral perampanel (6 mg)
  • Placebo — DRUG
    Oral placebo

Study Details

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.

Key Dates

Start date
Sep 7, 2023
Status verified
May 2026
Primary completion
Dec 31, 2032
Completion
Dec 31, 2032

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: ketamine plus perampanel
    A screening session is conducted to ensure that the subject can safely receive perampanel and ketamine (physical exam, blood and urine analyses, electrocardiogram, drug and alcohol testing). The participant will then receive 6 milligrams (mg) oral perampanel and intravenous ketamine. Participants will then undergo a 2-hour magnetic resonance imagining (MRI) scan. The following day, participants will return for an additional scan and symptom assessment.
  • Placebo Comparator: ketamine plus placebo
    A screening session is conducted to ensure that the subject can safely receive perampanel and ketamine (physical exam, blood and urine analyses, electrocardiogram, drug and alcohol testing). The participant will then receive an oral placebo (in lieu of 6 mg oral perampanel) and intravenous ketamine. Participants will then undergo a 2-hour MRI scan. The following day, participants will return for an additional scan and symptom assessment.

Primary Outcome Measure

Prefrontal functional connectivity [ Time Frame: During ketamine infusion, approximately 2.5 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale UniversityNew HavenConnecticut06511
Naomi Drieson, PhD
[email protected]
203-508-7765

Find similar trials in New Haven, CT

By condition
DepressionPTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
Yale University· New Haven, CT

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