About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Methylphenidate (MPH)
DrugEach participate will receive one oral dose of 60mg methylphenidate.
[11C]raclopride
DrugThis is the radiotracer that will be used along with methylphenidate to quantify dopamine transmission in this study. It is experimental and used for imaging purposes.
Treatment groups
Trial outcomes
Primary outcomes
Dopamine transmission
Delta BPND of \[11C\]raclopride in the Associative Striatum
Conversion to syndromal psychosis
Development of a '6' on a P symptom of the SIPS
Secondary outcomes
Positive Symptoms
Total P symptom score on the SIPS
Negative Symptoms
Total N symptom score on the SIPS
Dopamine Transmission in the ventral striatum
Delta BPND (\[11C\]raclopride) in the Ventral striatum
Other outcomes
Baseline dopamine
Neuromelanin MRI in midbrain at baseline
Change in positive symptoms
Change in total SIPS positive symptoms
Change in negative symptoms
Change in total N symptoms on the SIPS
Locations
Sponsors and contacts
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New York State Psychiatric Institute
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Columbia University
Collaborator
Stony Brook Medicine
Collaborator
This trial is not recruiting at the moment. You can still explore other options: