A Multimodal Imaging Study of Dopamine in Early Psychosis (NCT06977308) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Multimodal Imaging Study of Dopamine in Early Psychosis
115 participantsStarted 2026-06-01
Plain-language summary
The development of new treatments for psychosis, a psychiatric condition that is prevalent and highly disabling despite antipsychotic medications, has been limited, in part, by a lack of information from brain imaging studies during the period that leads to the development of psychotic symptoms. In this project the investigators will use Positron Emission Tomography (PET) and neuromelanin-sensitive magnetic resonance imaging (NM-MRI) to examine a brain chemical that is involved in schizophrenia called dopamine and where it first becomes abnormal. The investigators will use multimodal PET/MR imaging (i.e., \[11C\]raclopride w/MPH challenge and NM-MRI) in the same CHR patients. The investigators will recruit 115 clinical high risk individuals. All subjects will undergo \[11C\]raclopride w/methylphenidate challenge and neuromelanin-MRI imaging along with clinical assessments. Patients will be followed every 3 months for two years or until conversion to psychosis, whichever comes first, to assess for conversion to psychosis and clinical outcomes.
Who can participate
Age range
18 Years – 30 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
. Males or females between 18 and 30 years old
. Capacity to give informed consent
. Clinical High Risk (i.e., APSS, GRDS, BIPS)
. Antipsychotic free for 3 weeks before the PET scan
. Clinically stable enough for the study
Exclusion criteria
. Any substance use disorder, of any severity, within the previous month (before PET scan; not including nicotine or caffeine)
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Dopamine transmission
Timeframe: From the first (before methylphenidate) to the second PET scans (one hour after methylphenidate) on Day 1 of the study
2
Conversion to syndromal psychosis
Timeframe: From administration of the study drug to either conversion to a syndromal psychotic disorder or 24 months, whichever comes first.
. Any current use of substance of abuse besides THC/marijuana/cannabis/nicotine/caffeine (on day of PET only)
. Daily tobacco use
. Pregnancy
. Lactation
. Presence of insulin-dependent diabetes
. IQ \< 70 (i.e., WTAR \< 6)
. Acute risk for suicide (i.e., score of 4-5 within the previous month or 6 within the previous 3 months on the CSSRS) or violence, or history of severe violent behavior that may be exacerbated by methylphenidate