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

Part of paid clinical trials in West Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT05786066
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Perampanel 6 MG — DRUG
    Perampanel will be administered 2.5 hours before Ketamine infusion
  • Ketamine — DRUG
    Ketamine infusion (0.5 mg/kg infusion over 40 minutes) will be administered 2.5 hours post perampanel or placebo administration.
  • Placebo — DRUG
    Placebo will be administered 2.5 hours before Ketamine infusion

Study Details

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).

Key Dates

Start date
Apr 3, 2023
Status verified
May 2026
Primary completion
Mar 31, 2033
Completion
Mar 31, 2033

Study Design

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

Arms

  • Experimental: Perampanel + Ketamine
    Participants will receive oral perampanel or placebo, in counterbalanced order, 2.5 hours before a standard, subanesthetic Ketamine infusion (0.5 mg/kg over 40 minutes). Ketamine infusions will be at least three weeks apart. Participants will refrain from caffeine and over-the-counter medication seven days before the infusion day.
  • Placebo Comparator: Placebo + Ketamine
    Participants will receive oral perampanel or placebo, in counterbalanced order, 2.5 hours before a standard, subanesthetic Ketamine infusion (0.5 mg/kg over 40 minutes). Ketamine infusions will be at least three weeks apart. Participants will refrain from caffeine and over-the-counter medication seven days before the infusion day.

Primary Outcome Measure

Change in suicidal ideations in response to Ketamine [ Time Frame: Baseline and 24 hours post infusion ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA Connecticut Healthcare SystemWest HavenConnecticut06516-

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By specialty
PsychiatryMental healthBehavioral health
By research site
VA Connecticut Healthcare System· West Haven, CT

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