Imaging SV2A in Mood Disorders (NCT02734602) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Imaging SV2A in Mood Disorders
United States130 participantsStarted 2016-04
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
. 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.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial uses PET scans to look at synaptic density in the brain — how many PET scans would I need to undergo, and are there any risks or side effects from that imaging process I should know about?
2Since this study is measuring synaptic changes in Major Depressive Disorder and PTSD rather than testing a new treatment, would participating actually change or affect my current care in any way?
3The trial is no longer actively recruiting — does that mean there's no chance of joining, and if so, are there similar imaging or synaptic research studies you'd recommend I look into instead?
4This appears to be an observational brain imaging study rather than a treatment trial — given where I am in my diagnosis, would you say it's more important right now to focus on establishing a treatment plan, or could participating in research like this fit alongside that?
5Since this study is measuring synaptic density at the point of greatest antidepressant response, does that mean I would need to already be on or starting an antidepressant to be considered, and how might that interact with whatever treatment path you're recommending for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evidence of synaptic changes in psychiatric disorders confirmed by PET data.
Timeframe: Through study completion date, an average of 5 years.
2
Evidence of synaptic density at time of its greatest anti-depressant response in psychiatric disorders confirmed with PET data.
Timeframe: Through study completion date, an average of 5 years.
. 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.
. Claustrophobia.
. Current psychosis, active suicidal or homicidal ideation.