Perampanel + Ketamine for Suicidal Thoughts

Phase 2

Recruiting

Led By Naomi Driesen, PhD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 24 hours post infusion

Summary

This trial looks at whether a drug called Ketamine can help treat depression and suicidal thoughts by affecting two types of receptors in the brain.

Who is the study for?

This trial is for adults with treatment-resistant depression, PTSD, or bipolar disorder who have suicidal thoughts. They must be educated to at least a 12th-grade level, not pregnant or breastfeeding, and agree to birth control if applicable. Participants should be stable on current psychotherapy or medication regimens for four weeks prior to the study and willing to avoid caffeine, drugs, and alcohol before treatments.

What is being tested?

The study tests whether Ketamine's effects on reducing depression and suicidal thoughts depend on AMPA receptors. It involves comparing Perampanel (an AMPA receptor blocker), Ketamine (a known NMDAR antagonist), and a placebo in participants with certain mood disorders.

What are the potential side effects?

Ketamine may cause disorientation, dizziness, nausea, increased blood pressure or heart rate changes shortly after infusion. Long-term side effects are less clear but could include cognitive changes or bladder issues with repeated use.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 24 hours post infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 24 hours post infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 24 hours post infusion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in antidepressant response to Ketamine

Change in suicidal ideations in response to Ketamine

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Perampanel + KetamineExperimental Treatment2 Interventions

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.

Group II: Placebo + KetaminePlacebo Group2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Perampanel 6 MG

2018

Completed Phase 4

~20

Ketamine

2011

Completed Phase 4