← Back to Search

Glutamate Receptor Modulator

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
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cerebral metabolic rate of oxygen (CMRO2)
Prefrontal functional connectivity
Secondary outcome measures
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
~1090

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH
2,786 Previous Clinical Trials
2,689,649 Total Patients Enrolled
Yale UniversityLead Sponsor
1,853 Previous Clinical Trials
2,738,511 Total Patients Enrolled
John Krystal, MDPrincipal InvestigatorYale University
2 Previous Clinical Trials
133 Total Patients Enrolled

Media Library

Ketamine (Glutamate Receptor Modulator) Clinical Trial Eligibility Overview. Trial Name: NCT05915013 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I meet the requirements to join this investigation?

"To participate in this clinical trial, potential patients must have a diagnosis of bipolar disorder and be aged between 18 and 55. A total pool of 50 individuals are being sought out for the study."

Answered by AI

Is this trial accepting new participants?

"According to clinicaltrials.gov, this study is no longer recruiting participants, with the original posting date being July 30th 2023 and last update on June 26th 2023. However, there are still 1,327 other trials looking for prospective candidates at present."

Answered by AI

Has the FDA authorized ketamine plus perampanel for therapeutic use?

"Despite limited clinical data to support both efficacy and safety, the risk profile associated with ketamine plus perampanel received a score of 1."

Answered by AI

Is elder participation accepted for this experiment?

"To be accepted into this clinical trial, patients must have reached the age of majority and not yet exceeded 55 years old. Alternatively, there are 172 trials specifically for people under 18 or 976 studies that involve individuals over 65."

Answered by AI

Who else is applying?

What site did they apply to?
Yale University
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

I have tried more then 10 medications.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response
2023. "Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05915013.
All > Mdd > Bipolar Disorder
~33 spots leftby Dec 2032
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top