RecruitingDepressive Disorder, MajorPost Traumatic Stress Disorder
Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response
Eligible age
18–60 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: Yale University
You may qualify if…
- ✓ 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.
- ✓ Participants will meet DSM-5 Criteria for MDD as determined by the SCID-5
- ✓ All participants given ketamine must be engaged in treatment outside of the research protocol. Those who are not currently in treatment may be referred for treatment.
- ✓ Individuals who are receiving pharmacotherapy for depression must have been receiving the current medication and dose for 4 weeks before randomization. In addition, they should have a plan to continue the current regime of pharmacotherapy for the duration of the trial.
- ✓ Individuals who are receiving psychotherapy must have been in treatment for four weeks and should have a plan to continue the current regime of psychotherapy for the duration of the trial.
You may not qualify if…
- ✕ 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.
- ✕ Neurological disorder excluding migraine headaches or more than mild head injury. Individuals with migraines will not complete any ketamine infusion visits within 24 hours of a migraine. More than mild head injury is indicated by the presence of any of the following:
- ✕ 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.
- ✕ Concussive symptoms as defined above in the first week after injury causing more than one day impairment in typical duties.
- ✕ Four or more concussive events of less severity than the above will also be grounds for exclusion. These events would include post-trauma symptoms such as the individual being dazed, seeing stars, unconscious for less than one half hour, or post-traumatic amnesia of less than an hour.
- ✕ Current therapeutic treatment with ketamine
Where it's recruiting
Connecticut
New Haven
Source: ClinicalTrials.gov · NCT05915013 · last updated 2026-05-06