Actively Recruiting
Imaging SV2A in Mood Disorders
Led by Yale University · Updated on 2025-04-11
130
Participants Needed
1
Research Sites
569 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
V
VA Office of Research and Development
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Imaging SV2A in Mood Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects must be 18 to 70 years old
- Must speak English
- No other DSM-5 diagnosis besides those required below
- For depressed subjects: Meet DSM-5 criteria for Major Depressive Disorder and current depressive episode
- Depressed subjects may be treatment or non-treatment seeking and understand the study is for research only
- Healthy controls: No current or past DSM-5 diagnosis
- PTSD subjects: Current Post-Traumatic Stress Disorder
- Bipolar subjects: Meet DSM-5 criteria for bipolar disorder
- Subjects undergoing ketamine treatment must meet DSM-5 criteria for Major Depressive Disorder and current depressive episode and be undergoing ketamine treatment
You will not qualify if you...
- History of significant medical illness contraindicating participation
- Lifetime history of neurological abnormalities including seizure disorder, cerebrovascular or neoplastic lesions, neurodegenerative disorders, or significant head trauma with post-traumatic amnesia over 24 hours
- Full scale IQ below 70
- Contraindications to MRI such as claustrophobia or ferromagnetic objects including braces
- Pregnancy or breastfeeding
- Recent substance use disorder (except nicotine and marijuana) within 6 months to 1 year
- Claustrophobia
- Current psychosis or active suicidal or homicidal ideation
- Positive urine toxicology screen (except marijuana)
- Contraindications to PET such as cancer history or poor venous access
- Recent radiation exposure exceeding FDA limits
- Blood pressure over 130/80 for ketamine challenge or over 140/90 for others
- Bleeding disorders or anticoagulant use
- Blood donation within 8 weeks before study
- MDD or PTSD with psychotic features
- Low hematocrit or hemoglobin levels
- Weight under 110 lbs for participants who will have blood drawn at volumes similar to blood donation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
PET Center
New Haven, Connecticut, United States, 06519
Actively Recruiting
Research Team
S
Sarah B, MA
CONTACT
N
Nicole D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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