Status:
NOT_YET_RECRUITING
A Multimodal Imaging Study of Dopamine in Early Psychosis
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Columbia University Irving Medical Centre
Conditions:
Clinical High Risk for Psychosis (CHR)
Eligibility:
All Genders
18-30 years
Phase:
PHASE1
Brief 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 f...
Detailed Description
A large body of evidence suggests that abnormal striatal dopamine (DA) transmission is a key pathophysiological phenomenon in psychosis, mainly within the associative striatum (AST). However, it remai...
Eligibility Criteria
Inclusion
- 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
- Any substance use disorder, of any severity, within the previous month (before PET scan; not including nicotine or caffeine)
- 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
- Presence of metallic objects in the body
- Lifetime exposure to radiation in the workplace (i.e., being badged for radiation exposure), or exposure to radiation in the context of research protocol within the previous year that exceeds annual limits
- More than one risk factor for coronary artery disease (e.g., smoking, hyperlipidemia, sedentary lifestyle)
- Hypertension
- Presence of clinically significant brain abnormalities. \[For PET Scan Only\]
- Previous adverse reaction to stimulants that would preclude receiving methylphenidate
- Presence or positive history of any cardiovascular disease, medical or neurological condition that would preclude methylphenidate administration or participation in this study
- A history of bipolar disorder Type 1, or any history of syndromal psychosis
- Lack of effective birth control
Key Trial Info
Start Date :
March 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2030
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT06977308
Start Date
March 1 2026
End Date
October 1 2030
Last Update
December 17 2025
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