RECRUITING

Imaging SV2A in Mood Disorders

Conditions

Major Depressive Disorder Post-Traumatic Stress Disorder depression sv2a ketamine PET

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Imaging SV2A in Mood Disorders

Quick Facts

Study Start:2016-04

Study Completion:2027-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT02734602

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.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Sarah B, MA

CONTACT

203-737-7066

Nicole D

CONTACT

203-737-6884

Principal Investigator

Irina Esterlis, PhD

PRINCIPAL_INVESTIGATOR

Yale School of Medicine

Study Locations (Sites)

PET Center

New Haven, Connecticut, 06519

United States

Collaborators and Investigators

Sponsor: Yale University

Irina Esterlis, PhD, PRINCIPAL_INVESTIGATOR, Yale School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-04

Study Completion Date2027-03

Study Record Updates

Study Start Date2016-04

Study Completion Date2027-03

Terms related to this study

Keywords Provided by Researchers

depression
post-traumatic stress disorder
sv2a
ketamine
PET

Additional Relevant MeSH Terms

Major Depressive Disorder
Post-Traumatic Stress Disorder