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Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response

ConditionsDepressive Disorder, MajorPost Traumatic Stress Disorder
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

This trial does not accept healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

  • Ketamine

    Drug

    Intravenous ketamine

  • Perampanel

    Drug

    Oral perampanel (6 mg)

  • Placebo

    Drug

    Oral placebo

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: ketamine plus perampanelExperimental treatment 2 interventions
Group B: ketamine plus placeboPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Prefrontal functional connectivity

This outcome will be assessed via functional magnetic resonance imaging (fMRI).

Time frame
During ketamine infusion, approximately 2.5 hours
2

Cerebral metabolic rate of oxygen (CMRO2)

This outcome will be assessed via fMRI.

Time frame
During ketamine infusion, approximately 2.5 hours.

Secondary outcomes

1

Clinical improvement.

This outcome will be assessed by the Hamilton Depression Inventory, a clinician-rated instrument.

Time frame
24 hours post-infusion

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yale University

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov
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