Schizophrenia and Other Psychotic DisordersSV2NCT03995121
SV2 PET Imaging With [11C]APP311
An observational study of Schizophrenia and Other Psychotic Disorders and Cannabis Use Disorder, run by Yale University at 1 site in United States.
Trial summary
The aim of this study is to evaluate a new SV2A tracer, [11C]APP311, in healthy aging and neuropsychiatric disorders including psychotic disorders and cannabis use disorders. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia and Other Psychotic Disorders, Cannabis Use Disorder, Healthy
- What is being tested?
- [11C]APP311
- Type of treatment
- Injection or infusion
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2017to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Recruiting Subjects with Schizophrenia and other Psychotic disorders Cannabis Use Disorder Healthy controls
Who may be able to join
- Willing and able to give voluntary written informed consent
- Male and Female subjects, age 18 to 65 years, inclusive
Who cannot join
- MRI metal exclusions and claustrophobia.
- Education completed is less than 12 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Conneticut Mental Health Center
New Haven, Connecticut, 06519
About this study
Official title: Synaptic Density in Psychiatric Disorders Using SV2A Receptor PET Imaging With [11C]APP311
The aim of this study is to evaluate a new SV2A tracer, [11C]APP311, in healthy aging and neuropsychiatric disorders including psychotic disorders and cannabis use disorders.
Read the detailed description
The overall goal of this protocol is to study synaptic density in two psychiatric disorders (namely schizophrenia and other psychotic disorders, and cannabis use disorder) with this exciting new PET tracer. Secondary outcomes will include electroencephalography (EEG). A battery of EEG paradigms assessing sensory, perceptual, and cognitive functions will also be administered. The primary dependent measures will be traditional event related potentials (ERPs; e.g. latency and amplitude) as well as time X frequency analysis (inter-trial coherence and spectral power).
- Being tested
- [11C]APP311
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[11C]APP311Drug
It has been shown that radiotracer [11C]APP311 (aka [11C]UCB-J) displays high specificity and selectivity for the synaptic vesicle protein SV2A. Since this protein is expressed ubiquitously in active synapses, this tracer has the potential to be a general purpose tool for quantitative imaging of synaptic density.
| Study group | Role | What they receive |
|---|---|---|
| Schizophrenia and other psychotic disorders | For each [11C]APP311 PET scan, up to 20 mCi of [11C]APP311 will be administered by infusion pump, followed by up to 120 minutes of dynamic PET data acquisition. Receives: Drug: [11C]APP311 | |
| Cannabis Use Disorder | For each [11C]APP311 PET scan, up to 20 mCi of [11C]APP311 will be administered by infusion pump, followed by up to 120 minutes of dynamic PET data acquisition. Receives: Drug: [11C]APP311 | |
| Healthy Control | For each [11C]APP311 PET scan, up to 20 mCi of [11C]APP311 will be administered by infusion pump, followed by up to 120 minutes of dynamic PET data acquisition. Receives: Drug: [11C]APP311 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Synaptic density in psychiatric disorders using SV2A receptor PET Imaging with [11C]APP311
To compare synaptic vesicle protein 2A (SV2A) density in two groups of subjects with psychiatric disorders (namely 'schizophrenia and other psychotic disorders', and 'cannabis use disorder') to that in healthy controls using the PET radiotracer 11C-APP311
Measured: One test day (one time point).
Secondary outcomes (1)
Correlation of Synaptic density with cognition and EEG
To correlate SV2A density with concurrent measures of information processing such as cognitive performance on a neuropsychiatric battery and electroencephalographic (EEG) measures
Measured: One test day (one time point).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2019
- Study start1 Dec 2017
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia and Other Psychotic DisordersStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Deepak C. D'Souza, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03995121
- Sponsor's protocol ID
- 2000021592
- Other IDs
- 1R01DA054314-01, 36C24820C0079
- Acronym
- SV2
- Status last verified
- Oct 2026
- First submitted
- 19 Jun 2019
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synaptic Density in Psychiatric Disorders Using SV2A Receptor PET Imaging With [11C]APP311
- ClinicalTrials.gov ID
- NCT03995121
- Acronym / sponsor ID
- SV2 / 2000021592
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate a new SV2A tracer, [11C]APP311, in healthy aging and neuropsychiatric disorders including psychotic disorders and cannabis use disorders.
Detailed description
The overall goal of this protocol is to study synaptic density in two psychiatric disorders (namely schizophrenia and other psychotic disorders, and cannabis use disorder) with this exciting new PET tracer. Secondary outcomes will include electroencephalography (EEG). A battery of EEG paradigms assessing sensory, perceptual, and cognitive functions will also be administered. The primary dependent measures will be traditional event related potentials (ERPs; e.g. latency and amplitude) as well as time X frequency analysis (inter-trial coherence and spectral power).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Schizophrenia and other psychotic disorders | – | Drug: [11C]APP311For each [11C]APP311 PET scan, up to 20 mCi of [11C]APP311 will be administered by infusion pump, followed by up to 120 minutes of dynamic PET data acquisition. |
| Cannabis Use Disorder | – | Drug: [11C]APP311For each [11C]APP311 PET scan, up to 20 mCi of [11C]APP311 will be administered by infusion pump, followed by up to 120 minutes of dynamic PET data acquisition. |
| Healthy Control | – | Drug: [11C]APP311For each [11C]APP311 PET scan, up to 20 mCi of [11C]APP311 will be administered by infusion pump, followed by up to 120 minutes of dynamic PET data acquisition. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Recruiting Subjects with Schizophrenia and other Psychotic disorders Cannabis Use Disorder Healthy controls
Key inclusion criteria (2 listed)
- Willing and able to give voluntary written informed consent
- Male and Female subjects, age 18 to 65 years, inclusive
Key exclusion criteria (2 listed)
- MRI metal exclusions and claustrophobia.
- Education completed is less than 12 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [11C]APP311It has been shown that radiotracer [11C]APP311 (aka [11C]UCB-J) displays high specificity and selectivity for the synaptic vesicle protein SV2A. Since this protein is expressed ubiquitously in active synapses, this tracer has the potential to be a general purpose tool for quantitative imaging of synaptic density. | Drug | Cannabis Use Disorder, Healthy Control, Schizophrenia and other psychotic disorders |
Primary outcome
Synaptic density in psychiatric disorders using SV2A receptor PET Imaging with [11C]APP311
Time frame: One test day (one time point).
To compare synaptic vesicle protein 2A (SV2A) density in two groups of subjects with psychiatric disorders (namely 'schizophrenia and other psychotic disorders', and 'cannabis use disorder') to that in healthy controls using the PET radiotracer 11C-APP311
1 secondary outcome
Correlation of Synaptic density with cognition and EEG
Time frame: One test day (one time point).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Other Psychotic Disorders and Cannabis Use Disorder, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Synaptic density in psychiatric disorders using SV2A receptor PET Imaging with [11C]APP311 (time frame: One test day (one time point).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.