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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Methylphenidate (MPH)

    Drug

    Each participate will receive one oral dose of 60mg methylphenidate.

  • [11C]raclopride

    Drug

    This 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

115 Participants
are divided into 1 treatment group
Group A: MethylphenidateExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Dopamine transmission

Delta BPND of \[11C\]raclopride in the Associative Striatum

Time frame
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

Development of a '6' on a P symptom of the SIPS

Time frame
From administration of the study drug to either conversion to a syndromal psychotic disorder or 24 months, whichever comes first.

Secondary outcomes

1

Positive Symptoms

Total P symptom score on the SIPS

Time frame
At time zero before administration of methylphenidate
2

Negative Symptoms

Total N symptom score on the SIPS

Time frame
At time zero before administration of methylphenidate
3

Dopamine Transmission in the ventral striatum

Delta BPND (\[11C\]raclopride) in the Ventral striatum

Time frame
From the first (before methylphenidate) to the second PET scans (one hour after methylphenidate) on Day 1 of the study

Other outcomes

1

Baseline dopamine

Neuromelanin MRI in midbrain at baseline

Time frame
At time zero before administration of methylphenidate
2

Change in positive symptoms

Change in total SIPS positive symptoms

Time frame
From time zero before administration of methylphenidate to either conversion to a syndromal psychotic disorder or 24 months, whichever comes first.
3

Change in negative symptoms

Change in total N symptoms on the SIPS

Time frame
From time zero before administration of methylphenidate to either conversion to a syndromal psychotic disorder or 24 months, whichever comes first.

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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: