Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorYale University
About this trial
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.
Eligibility criteria
Qualifiers
Right-handed as determined by the Edinburgh Handedness Inventory
Current depression as indicated by a score greater than 17 on the full Hamilton Depression Rating Scale
Anti-depressant resistant depressive symptoms, defined by a history of failure of one or more adequate anti-depressant trials
Individuals who have previously received ketamine must have had a positive response. Individuals who report reduced depressive symptoms will be treated as ketamine responders and entered directly into the closed label trial.
Disqualifiers
A score on the Columbia Suicide Severity Rating Scale in the "intent" or "intent with plan" categories or judged by Dr. Krystal or Dr. Driesen to be at serious risk for suicide.
More than half hour unconsciousness after trauma
More than one hour post-traumatic amnesia
Concussive symptoms such as headache, memory problems, nausea/vomiting, irritability, ringing in the ears, dizziness, balance problems, difficulty concentrating or visual disturbances lasting more than one week after injury.
Trial design
Treatments tested in this trial
- Ketamine
- Perampanel
- Placebo
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Yale University
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov