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A Multimodal Imaging Study of Dopamine in Early Psychosis

Study acronym: MISDEP
StatusNot Yet Recruiting
PhasePhase 1
Started
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Record History

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  1. Notable Start date: Jun 1, 2026 to Oct 1, 2026v6
  2. Notable Start date: Mar 1, 2026 to Jun 1, 2026v5
  3. Minor Re-verified, no change to tracked fieldsv4
  4. Minor Interventions: Methylphenidate (MPH) (Drug) to Methylphenidate (MPH) (Drug), [11C]raclopride (Drug)
    • Collaborators: 2 to 3
    v3
  5. Notable Start date: Oct 1, 2025 to Mar 1, 2026v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06977308
Lead Sponsor New York State Psychiatric Institute
Collaborators: National Institute of Mental Health (NIMH), Columbia University, Stony Brook Medicine
Conditions
(from sponsor)
Clinical High Risk for Psychosis (CHR)
Enrollment 115 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov