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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
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
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
Find a Location
Who is running the clinical trial?
National Institute of Mental Health (NIMH)NIH
2,869 Previous Clinical Trials
2,777,486 Total Patients Enrolled
Yale UniversityLead Sponsor
1,907 Previous Clinical Trials
3,018,999 Total Patients Enrolled
John Krystal, MDPrincipal InvestigatorYale University
2 Previous Clinical Trials
133 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am receiving treatment besides the ketamine given in this study.My depression hasn't improved after trying at least one anti-depressant.I have not donated more than 500 mL of blood or lost a similar amount in the last 56 days.I have been in psychotherapy for 4 weeks and plan to continue during the trial.I have not taken monoamine oxidase inhibitors in the last 4 weeks.I have diabetes that requires insulin or is not well-controlled.I have taken ketamine before and it helped my depression.I have a neurological condition, but it's not migraines or a mild head injury.I am currently being treated with ketamine.I have had a positive response to ketamine treatment in the past.I have a history of HIV or Hepatitis B.I haven't had vagal nerve, ECT, or deep brain stimulation treatments in the last 2 weeks.I have been on the same depression medication and dose for at least 4 weeks.I have been taking topiramate, memantine, or barbiturates in the last two weeks.I have not taken any brain-affecting drugs or supplements in the week before my MRI.I won't drive or handle heavy machinery for 24 hours after my infusion.My depression score is above 17.I will receive ketamine in the early part of my menstrual cycle if possible.
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