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NCT02734602Active, not recruiting

Imaging SV2A in Mood Disorders

Source: ClinicalTrials.gov · Last updated 8 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
130 (estimated)
First submitted
17 Mar 2016
Start date
1 Apr 2016
Primary completion date
31 Jan 2027
Lead sponsor
Yale University
Diseases
Depression
NCT number
NCT02734602

What you commit to

  • Study type: Interventional
  • Planned participants: 130
  • From 1 Apr 2016 to the primary completion date, 31 Jan 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.
  • Previous or anticipated radiation exposure at work within one year of the proposed research PET scans that precludes study participation.
  • Arterial line exclusion: History of a bleeding disorder or currently taking anticoagulants (such as Coumadin, Heparin, Pradaxa, Xarelto).

Other illness

  • History of significant medical illness that would contraindicate study participation based on above criteria and PI/MD history review.
  • 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.
  • 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.
  • Contraindications to PET (e.g., past or current diagnosis of cancer, poor venous access for placement of venous lines).

Lab values

  • Hematocrit levels below 35 mg/dl, and/or hemoglobin levels below 10 mg/dl.

Other

  • Full scale IQ lower than 70.
  • 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.
  • Pregnancy or breast-feeding.
  • Claustrophobia.
  • Current psychosis, active suicidal or homicidal ideation.
  • Positive urine toxicology screen (except for marijuana).
  • Blood pressure \>130/80 (for Aim 2, ketamine challenge); blood pressure \>140/90 (non-ketamine groups).
  • Arterial line exclusion: Blood donation within eight weeks of the start of the study.
  • Current diagnosis of MDD or PTSD with psychotic features.
  • 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.

Who the study is looking for

  • General inclusion criteria:
    • Subjects will be 18-70 years old,
    • English speaking,
    • No other DSM-5 diagnosis present, besides required as below.
  • Meet DSM-5 diagnostic criteria for Major Depressive Disorder, and for a current depressive episode.
  • Treatment or non-treatment seeking who understand that this study is for research purposes only.
  • 1\. No current, or history of any DSM-5 diagnosis.
  • 1\. Current Post Traumatic Stress Disorder.
  • 1\. Meet DSM-5 diagnostic criteria for bipolar disorder.
  • 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).
  • Undergoing ketamine treatment.

Age in the registry: 18 years to 70 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
PET Center
Coordinator of this site? Confirm its status
New HavenUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.