NCT05786066

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

The investigators will use the NMDAR antagonist Ketamine combined with the AMPAR antagonist perampanel to test the following hypotheses: Primary Hypotheses: 1. Perampanel pre-treatment will attenuate Ketamine's reduction of suicidal ideation as assessed 24 hours after drug infusion with a well-established suicidal ideation inventory that has been shown to be sensitive to Ketamine's anti-suicidal effects. 2. Perampanel pre-treatment will attenuate the antidepressant response to Ketamine as assessed 24 hours after drug infusion with the Hamilton Depression Inventory, a well-established depression inventory used extensively to test Ketamine treatment effectiveness. 3. Exploratory: Perampanel pre-treatment reduces the anti-suicidal effect of Ketamine directly as well as indirectly through depression symptom remission. Eligibility will be determined by psychiatric interview, rating scales and questionnaires, and a complete physical exam with electrocardiogram and labs. Individuals found eligible will receive 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 and individuals will complete follow-up assessments through interview and electronic diary.

Conditions

• Depressive Disorder
• Major Depressive Disorder
• Bipolar Disorder
• Post Traumatic Stress Disorder
• Suicidal Ideation

Interventions

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

Timeline

• Start date: 2023-04-03
• Primary completion: 2033-03-01
• Completion: 2033-03-01
• First posted: 2023-03-27
• Last updated: 2024-12-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study