What this study is
The purpose of this study is to utilize the radioactive positron emission tomography (PET) tracer [11C]UCB-J to test the neural synaptic pruning hypothesis of schizophrenia. This imaging method allows for the quantification of synaptic density in the living human brain and has the unprecedented ability to directly examine the synaptic pathology underlying neuropsychiatric disease. The neural synaptic pruning hypothesis posits that a key pathogenic process of schizophrenia is the over-exuberant elimination of neural synapses during development. The confirmation of reduced synaptic density in schizophrenia as evidenced by [11C]UCB-J has the potential to lead to a number of ground-breaking clinical innovations, such as laboratory-based diagnostics and prognostics, and novel, disease-modifying treatments.
What's being tested
- [11C]UCB-J radiotracer
Intervention · DRUG
I.V. bolus administration of up to 15 mCi (equivalent to 0.3 rems) in the antecubital vein
- PET-MR
Intervention · DEVICE
Positron emission tomography and magnetic resonance imaging, with a scan duration of up to 120 minutes
Study details
- Sponsor
- Davidzon, Guido, M.D.
- Conditions
- Schizophrenia
- Enrolling
- 60 people
- Starts
- 2019-08-01
- Est. completion
- 2025-12
- Design
- Open-label, non-randomized, parallel groups, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 65 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- 18 - 65 years in age
- For SZ participants:; On a stable medication regimen for at least two weeks prior to testing; A clinical diagnosis of schizophrenia, schizophreniform, or schizoaffective disorder; Able to complete a PET-MR scan without the use of sedation
You can't join if
- Active substance use within three months of testing
- 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
- For HC participants:; Presence of a first degree relative with a psychotic disorder; Lifetime diagnosis of major psychiatric illness
- For SZ participants:; Unstable psychiatric symptoms at the time of testing, e.g. acute suicidality, prominent psychosis, or behavioral dyscontrol
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openVA Palo Alto Health Care System
Palo Alto, California, United States
RecruitingStanford University
Stanford, California, United States
Recruiting
Study team
Sponsor
Davidzon, Guido, M.D.
Study ID 46106
Principal investigator
Jong H Yoon, MD
Stanford University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.