Sponsor study identifier
Secondary identifiers
interventional
50
1 country
1
Study Start
September 7, 2023
Actual (reported)Primary Completion
December 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The proposed study will assess the combined effect of perampanel and ketamine on the anti-depressant response in individuals with treatment resistant depression. The purpose of this study is to test the hypothesis that stimulation of Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid receptors (AMPAR) is critical to the anti-depressant response of ketamine.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 13, 2023
Actual (reported)June 22, 2023
Actual (reported)September 7, 2023
Actual (reported)December 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Prefrontal functional connectivity
This outcome will be assessed via functional magnetic resonance imaging (fMRI).
During ketamine infusion, approximately 2.5 hours
Cerebral metabolic rate of oxygen (CMRO2)
This outcome will be assessed via fMRI.
During ketamine infusion, approximately 2.5 hours.
Clinical improvement.
24 hours post-infusion
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.
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.
Intravenous ketamine
Oral perampanel (6 mg)
Yale University
New Haven, Connecticut, 06511, United States
John Krystal, MD
Yale University Medical School
Naomi R Driesen, Ph.D.
Yale University Medical School
First Submitted
June 13, 2023
First Posted
June 22, 2023
Study Start
September 7, 2023
Actual (reported)Biomarkers of Fast Acting Therapies in Major Depression
Oral placebo
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
December 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 6, 2026
Record last verified: 2026-05
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Source: ClinicalTrials.gov.
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