Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2019-12-01
2025-02-01
Brief Summary
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Detailed Description
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The finding of a marked increase in synaptic density in participants who respond to rTMS treatment would point to the possibility of developing new treatments with the potential to modify disease through mitigating, preventing or remediating synaptic loss.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Major Depression Disorder Participants
Participants will undergo positron emission tomography-magnetic resonance (PET-MR) imaging using the \[11C\]UCB-J radiotracer before and after Repetitive Transcranial Magnetic Stimulation (rTMS) treatment
[11C]UCB-J radiotracer
I.V. bolus administration of up to 15 mCi (equivalent to 0.3 rems) in the antecubital vein per injection
PET-MR
Positron emission tomography and magnetic resonance imaging, with a scan duration of up to 120 minutes
Interventions
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[11C]UCB-J radiotracer
I.V. bolus administration of up to 15 mCi (equivalent to 0.3 rems) in the antecubital vein per injection
PET-MR
Positron emission tomography and magnetic resonance imaging, with a scan duration of up to 120 minutes
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* U.S. Veteran
* Diagnosis of MDD
* On a stable medication regimen for at least two weeks prior to testing
* Stable social environment and housing to enable regular attendance at clinic visits
* Ability to undergo cognitive testing, clinical assessments, and PET/MR scans
* Stable medical health
* Will undergo rTMS treatment for MDD at the VA Palo Alto
* Able to complete a PET-MR scan without the use of sedation
Exclusion Criteria
* IQ \< 70
* Major medical neurological illness or significant head trauma
* Pregnancy or breastfeeding
* Contraindication to MR scanning, including magnetic-resonance incompatible metal or hardware including pacemakers, cochlear implants, and bullets near a critical organ
* Weight \> 350 lbs or a large body habitus that MR scanner cannot accommodate
* History of or current claustrophobia
* Inability to comply with basic study requirements such as following directions and punctuality
* Acute or unstable chronic medical illness that would affect participation or compliance with study procedures, e.g. unstable angina
* Unstable psychiatric symptoms that precludes consistent participation in the study, e.g. active current suicidal intent or plan, severe psychosis
* Inability to undergo PET/MR scan, e.g. claustrophobia, presence of ferromagnetic objects in subject's body
18 Years
70 Years
ALL
No
Sponsors
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Stanford University
OTHER
Davidzon, Guido, M.D.
OTHER
Responsible Party
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Jong Yoon
Associate Professor of Psychiatry and Behavioral Sciences
Principal Investigators
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Jong H Yoon, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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VA Palo Alto Health Care System
Palo Alto, California, United States
Stanford University
Stanford, California, United States
Countries
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References
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Finnema SJ, Nabulsi NB, Mercier J, Lin SF, Chen MK, Matuskey D, Gallezot JD, Henry S, Hannestad J, Huang Y, Carson RE. Kinetic evaluation and test-retest reproducibility of [11C]UCB-J, a novel radioligand for positron emission tomography imaging of synaptic vesicle glycoprotein 2A in humans. J Cereb Blood Flow Metab. 2018 Nov;38(11):2041-2052. doi: 10.1177/0271678X17724947. Epub 2017 Aug 9.
Chen MK, Mecca AP, Naganawa M, Finnema SJ, Toyonaga T, Lin SF, Najafzadeh S, Ropchan J, Lu Y, McDonald JW, Michalak HR, Nabulsi NB, Arnsten AFT, Huang Y, Carson RE, van Dyck CH. Assessing Synaptic Density in Alzheimer Disease With Synaptic Vesicle Glycoprotein 2A Positron Emission Tomographic Imaging. JAMA Neurol. 2018 Oct 1;75(10):1215-1224. doi: 10.1001/jamaneurol.2018.1836.
Wu Y, Carson RE. Noise reduction in the simplified reference tissue model for neuroreceptor functional imaging. J Cereb Blood Flow Metab. 2002 Dec;22(12):1440-52. doi: 10.1097/01.WCB.0000033967.83623.34.
Chervyakov AV, Chernyavsky AY, Sinitsyn DO, Piradov MA. Possible Mechanisms Underlying the Therapeutic Effects of Transcranial Magnetic Stimulation. Front Hum Neurosci. 2015 Jun 16;9:303. doi: 10.3389/fnhum.2015.00303. eCollection 2015.
Holmes SE, Scheinost D, Finnema SJ, Naganawa M, Davis MT, DellaGioia N, Nabulsi N, Matuskey D, Angarita GA, Pietrzak RH, Duman RS, Sanacora G, Krystal JH, Carson RE, Esterlis I. Lower synaptic density is associated with depression severity and network alterations. Nat Commun. 2019 Apr 4;10(1):1529. doi: 10.1038/s41467-019-09562-7.
Other Identifiers
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54574
Identifier Type: -
Identifier Source: org_study_id