Ketamine Treatment Effects on Synaptic Plasticity... — Clinical Trial Details

This study evaluates ketamine's effects on synaptic density in adults with current major depressive disorder using [11C]UCB-J PET before and after a course of four subanesthetic IV ketamine infusions (0.5 mg/kg each) administered over two weeks.

Primary aims are to quantify changes in synaptic density following ketamine treatment and to explore synaptic density as a mediator and predictor of sustained antidepressant response; participants undergo inpatient admission for imaging and treatment at NYSPI.

Outcomes include PET measures of SV2A binding, clinical depression ratings (HAM-D), and safety/tolerability assessments; imaging uses [11C]UCB-J with robust test-retest reliability to detect longitudinal changes.

Participants

Ages

18 – 55

Sexes

Male & Female

BMI

Psychosis History

Inclusion Criteria

Inclusion Criteria:
Unipolar, major depressive episode (MDE), with 17-item Hamilton Depression Rating Scale score ≥16. Patients may be psychiatric medication-free, or if currently taking psychiatric medication, not responding adequately as evidenced by current MDE.
18-55 years old
Female patients of child-bearing potential must be willing to use an acceptable form of birth control during study participation such as condoms, diaphragm, oral contraceptive pills.
Must be enrolled in division's umbrella research protocol
Able to provide informed consent
Agrees to voluntary admission to an inpatient research unit at The New York State Psychiatric Institute (NYSPI) for baseline PET imaging and Magnetic Resonance Imaging (MRI), ketamine infusion, and repeat PET imaging

Exclusion Criteria

Exclusion Criteria:
Unstable medical or neurological illness including: A) baseline hypertension (BP>140/90); B) significant history of cardiovascular illness; C) Platelet count < 80,000 cells/uL; and D) Hemoglobin < 11 g/dL for females and < 12 g/dL for males
Significant electrocardiogram (ECG) abnormality (e.g., Ventricular tachycardia, evidence of myocardial ischemia, symptomatic bradycardia, unstable tachycardia, second degree (or greater) atrioventricular (AV) block).
Pregnancy, currently lactating, or planning to conceive during the course of study participation.
Diagnosis of bipolar disorder or current psychotic symptoms.
Current or past ketamine use disorder (lifetime); any drug or alcohol use disorder within past 6 months
Inadequate understanding of English.
Prior ineffective trial of or adverse reaction to ketamine.
A neurological disease or prior head trauma with evidence of cognitive impairment.
Subjects who endorse a history of prior head trauma and score ≥ 1.5 standard deviations below the mean on the Trailmaking A & B will be excluded from study participation.
Metal implants or paramagnetic objects contained within the body which may present a risk to the subject or interfere with the MRI scan.
Current, past, or anticipated exposure to radiation that may interfere with PET/MRI participation.
Claustrophobia significant enough to interfere with MRI scanning
Weight that exceeds 325 lbs or inability to fit into MRI scanner
Individuals taking prescribed opioid medication, using opioids recreationally, or taking naltrexone at the time of enrollment
Daily use of benzodiazepine, zolpidem (Ambien), zaleplon (Sonata), or eszopiclone (Lunesta) for ≥2 weeks at time of consent

Company

Product

Legal

Ketamine Treatment Effects on Synaptic Plasticity in Depression

Detailed Description

Study Protocol

Preparation

Locations

Dosing

Integration

Study Arms & Interventions

Ketamine

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

Sponsors & Collaborators