Imaging SV2A in Mood Disorders

Description

This study is designed to examine SV2A density in MDD and PTSD as a correlate of synaptic density, and to determine whether ketamine administration will reverse the synaptic loss in vivo in human subjects. To our knowledge, this is the first human study to examine SV2A in vivo in MDD and PTSD and to use the first known drug (ketamine) that rapidly reverses synaptic loss to determine whether ketamine administration could restore some of the structural changes associated with depression and PTSD. After a screening process to determine eligibility, all subjects will participate in an MRI, and 2-3 PET scans with the administration of ketamine for one of the scans. Cognitive testing and a stress test may also be done on scan days.

Conditions

Major Depressive Disorder, Post-Traumatic Stress Disorder

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Study Overview

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Study Details

Study overview

This study is designed to examine SV2A density in MDD and PTSD as a correlate of synaptic density, and to determine whether ketamine administration will reverse the synaptic loss in vivo in human subjects. To our knowledge, this is the first human study to examine SV2A in vivo in MDD and PTSD and to use the first known drug (ketamine) that rapidly reverses synaptic loss to determine whether ketamine administration could restore some of the structural changes associated with depression and PTSD. After a screening process to determine eligibility, all subjects will participate in an MRI, and 2-3 PET scans with the administration of ketamine for one of the scans. Cognitive testing and a stress test may also be done on scan days.

Imaging SV2A in Mood Disorders

Imaging SV2A in Mood Disorders

Condition
Major Depressive Disorder
Intervention / Treatment

-

Contacts and Locations

New Haven

PET Center, New Haven, Connecticut, United States, 06519

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * General
  • 1. History of significant medical illness that would contraindicate study participation based on above criteria and PI/MD history review.
  • 2. Lifetime history of neurologic abnormality including seizure disorder, cerebrovascular or neoplastic lesion, neurodegenerative disorder, or significant head trauma resulting in post-traumatic amnesia \>24 hours.
  • 3. Full scale IQ lower than 70.
  • 4. Contraindication to MRI scanning including claustrophobia and presence of a ferromagnetic object, including orthodontic braces. All participants will be screened for metal objects by the same methods used for routine clinical MRI scanning.
  • 5. Pregnancy or breast-feeding.
  • 6. Met DSM-5 criteria for mild substance use disorder (except nicotine and marijuana) within the past 6 months or met DSM-5 criteria for moderate to severe substance use disorder within the past year.
  • 7. Claustrophobia.
  • 8. Current psychosis, active suicidal or homicidal ideation.
  • 9. Positive urine toxicology screen (except for marijuana).
  • 10. Contraindications to PET (e.g., past or current diagnosis of cancer, poor venous access for placement of venous lines).
  • 11. History of prior radiation exposure for research purposes within the past year such that participation in this study would place them over FDA limits for annual radiation exposure.
  • 12. Previous or anticipated radiation exposure at work within one year of the proposed research PET scans that precludes study participation.
  • 13. Blood pressure \>130/80 (for Aim 2, ketamine challenge); blood pressure \>140/90 (non-ketamine groups).
  • 14. Arterial line exclusion: History of a bleeding disorder or currently taking anticoagulants (such as Coumadin, Heparin, Pradaxa, Xarelto).
  • 15. Arterial line exclusion: Blood donation within eight weeks of the start of the study.
  • 16. Current diagnosis of MDD or PTSD with psychotic features.
  • 17. Hematocrit levels below 35 mg/dl, and/or hemoglobin levels below 10 mg/dl.
  • 18. Weight under 110 lbs for subjects who will participate in portions of this study for which the blood draw is at or above a typical blood donation.

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Yale University,

Irina Esterlis, PhD, PRINCIPAL_INVESTIGATOR, Yale School of Medicine

Study Record Dates

2027-03