Imaging SV2A in Mood Disorders
Major Depressive Disorder, Post-Traumatic Stress Disorder
About this trial
This is an interventional basic science trial for Major Depressive Disorder focused on measuring depression, post-traumatic stress disorder, sv2a, ketamine, PET
Eligibility Criteria
Inclusion Criteria:
General inclusion criteria:
- Subjects will be 18-70 years old,
- English speaking,
- No other DSM-5 diagnosis present, besides required as below.
Inclusion criteria for depressed subjects:
- 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.
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.
Exclusion Criteria:
- 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.
- 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.
- 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.
- Current psychosis, active suicidal or homicidal ideation.
- Positive urine toxicology screen (except for marijuana).
- Contraindications to PET (e.g., past or current diagnosis of cancer, poor venous access for placement of venous lines).
- 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.
- Blood pressure >130/80 (for Aim 2, ketamine challenge); blood pressure >140/90 (non-ketamine groups).
- History of a bleeding disorder or currently taking anticoagulants (such as Coumadin, Heparin, Pradaxa, Xarelto).
- Blood donation within eight weeks of the start of the study.
- Current diagnosis of MDD or PTSD with psychotic features.
- Hematocrit levels below 35 mg/dl, and/or hemoglobin levels below 10 mg/dl.
- 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.
Sites / Locations
- PET CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
No Intervention
Active Comparator
No Intervention
Single PET scan
PET scans and ketamine administration
PET scans for subjects undergoing ketamine treatment
Subjects will participate in 1 PET scan (up to 2 if cancelations occur) on the High Resolution Research Tomograph (HRRT), the highest resolution human brain scanner available, or the HR+ will be used to image subjects. Vital signs (blood pressure and pulse) will be obtained before and after radiotracer administration. Venous catheter(s) will be used for IV administration of the radiotracer and for venous blood sampling. An arterial catheter will be inserted by an experienced physician before the PET scan.
Subjects will participate in 2-3 PET scans (up to 4 if cancelations occur) on the High Resolution Research Tomograph (HRRT), the highest resolution human brain scanner available, or the HR+ will be used to image subjects. Vital signs (blood pressure and pulse) will be obtained before and after radiotracer administration. Venous catheter(s) will be used for IV administration of the radiotracer and for venous blood sampling. An arterial catheter will be inserted by an experienced physician before the PET scan. After a baseline scan, subjects will be administered a low dose of ketamine for the second scan. Bipolar subjects will not participate in any ketamine arms.
For subjects currently undergoing treatment with ketamine. Subjects will participate in 1-3 PET scans (up to 4 if cancelations occur) on the High Resolution Research Tomograph (HRRT), the highest resolution human brain scanner available, or the HR+ will be used to image subjects. Vital signs (blood pressure and pulse) will be obtained before and after radiotracer administration. Venous catheter(s) will be used for IV administration of the radiotracer and for venous blood sampling. An arterial catheter will be inserted by an experienced physician before the PET scan. Baseline scan will occur prior to initiation of ketamine treatment. Subsequent scans will occur after several treatments with ketamine and after completion of treatment. Bipolar subjects will not participate in any ketamine arms.