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New treatment option for Schizophrenia
Official title Imaging Synapses With [11C] UCB-J in the Human Brain
ClinicalTrials.gov ID: NCT04038840
What this study is testing
What is [11C]UCB-J radiotracer?
[11C]UCB-J radiotracer is an investigational medicine, being studied as a potential treatment for schizophrenia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join 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 likely 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...
- Weight \> 350 lbs or a large body habitus that MR scanner cannot accommodate
See the full eligibility criteria
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
- Stanford, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, California, United States; Stanford, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.