Ketamine + Perampanel for Depression

Phase 1

Recruiting

Led By John Krystal, MD

Research Sponsored by Yale University

Eligibility Criteria Checklist

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

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during ketamine infusion, approximately 2.5 hours

Summary

This trial will assess if combining two anti-depressant treatments can improve results in people with depression that hasn't responded to other treatments.

Who is the study for?

This trial is for right-handed individuals with treatment-resistant depression, scoring above 17 on the Hamilton Depression Scale. They must be undergoing or agree to start external therapy and maintain current medication doses throughout the trial. Participants should avoid caffeine, drugs, alcohol before MRI sessions and use birth control if applicable.

What is being tested?

The study tests whether activating AMPAR receptors enhances ketamine's anti-depressant effects in those unresponsive to standard treatments. It involves combining perampanel with ketamine versus a placebo to see if this improves depressive symptoms more effectively.

What are the potential side effects?

While not explicitly listed here, common side effects of ketamine can include disorientation, dizziness, nausea, increased blood pressure and heart rate; perampanel may cause mood changes, dizziness, fatigue.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during ketamine infusion, approximately 2.5 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during ketamine infusion, approximately 2.5 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and during ketamine infusion, approximately 2.5 hours for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Cerebral metabolic rate of oxygen (CMRO2)

Prefrontal functional connectivity

Secondary study objectives

Clinical improvement.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ketamine plus perampanelExperimental Treatment2 Interventions

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.

Group II: ketamine plus placeboPlacebo Group2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Perampanel

2014

Completed Phase 4

~2890

Ketamine

2011

Completed Phase 4

~1120