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Active, not recruitingNot applicable

Imaging SV2A in Mood Disorders

NCT02734602 · Yale University

Closed to entry
Status
Not accepting participants
Not applicable
Phase
130
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Evidence of synaptic changes in psychiatric disorders confirmed by PET data.

    Measured over Through study completion date, an average of 5 years.

  • Evidence of synaptic density at time of its greatest anti-depressant response in psychiatric disorders confirmed with PET data.

    Measured over Through study completion date, an average of 5 years.

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 70 Years
Ages
All
Sex
Accepted
Healthy volunteers
Inclusion Criteria: * General inclusion criteria: 1. Subjects will be 18-70 years old, 2. English speaking, 3. No other DSM-5 diagnosis present, besides required as below. Inclusion criteria for depressed subjects: 1. Meet DSM-5 diagnostic criteria for Major Depressive Disorder, and for a current depressive episode. 2. Treatment or non-treatment seeking who understand that this study is for research purposes only. Inclusion criteria for healthy controls: 1\. No current, or history of any DSM-5 diagnosis. Inclusion criteria for PTSD subjects: 1\. Current Post Traumatic Stress Disorder. Inclusion criteria for bipolar subjects: 1\. Meet DSM-5 diagnostic criteria for bipolar disorder. Inclusion criteria for subjects undergoing ketamine treatment 1. Meet DSM-5 diagnostic criteria for Major Depressive Disorder, and for a current depressive episode, as assessed by structured interview for DSM-5 diagnosis (SCID). 2. Undergoing ketamine treatment. Exclusion Criteria: 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.

Where

1 study site

FacilityCityRegionCountry
PET CenterNew HavenConnecticutUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT02734602 on ClinicalTrials.gov →

Last updated in the registry 2026-06-08. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits