A Multimodal Imaging Study of Dopamine in Early Psychosis

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-30
SponsorNew York State Psychiatric Institute

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

Qualifiers

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

Treatments tested in this trial

  • Methylphenidate (MPH)
  • [11C]raclopride

Treatment groups

115 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

New York State Psychiatric Institute

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

Columbia University

Collaborator

Stony Brook Medicine

Collaborator