RecruitingNCT07483294

Cerebellum-based Imaging Neural Markers for Antipsychotic Response

Cerebellar-cortical Circuitry and Prediction of Treatment Response in Early Psychosis


Sponsor

Northwell Health

Enrollment

120 participants

Start Date

Nov 1, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

This study will investigate neural markers in the cerebellar-cortical circuitry that predict treatment response to antipsychotics in first-episode psychosis. A total of 120 patients diagnosed with a first-episode psychotic disorder will be recruited. All subjects receive naturalistic treatment with either risperidone or aripiprazole for 12 weeks, with dosage and titration followed by standard clinical care. A comprehensive clinical and neuroimaging assessments will be performed before and after treatment.


Eligibility

Min Age: 16 YearsMax Age: 40 Years

Inclusion Criteria5

  • Diagnosis of a first-episode psychotic disorder including: schizophrenia, schizophreniform disorder, schizoaffective disorder, brief psychotic disorder, psychotic disorder NOS, bipolar disorder with psychosis, and major depressive disorder with psychosis;
  • Current positive symptoms rated \> 3 (moderate) on one or more of the BPRS psychosis items: conceptual disorganization, grandiosity, hallucinatory behavior, and unusual thought content;
  • At early phase of illness as defined by having taken antipsychotic drugs for a cumulative lifetime period of 8 weeks or less;
  • Age 16 to 40;
  • Competent to sign informed consent.

Exclusion Criteria7

  • Serious neurological or endocrine disorder or brain trauma;
  • Any medical condition which requires treatment with a medication with psychotropic effects;
  • Significant risk of suicidal or homicidal behavior;
  • Cognitive or language limitations, or any other factor that would preclude subjects providing informed consent;
  • Contraindications to antipsychotic monotherapy;
  • Contraindications to MR imaging (e.g. pacemaker);
  • Pregnancy by self report.

Interventions

DRUGRisperidone

Naturalistic treatment


Locations(1)

Zucker Hillside Hospital

Glen Oaks, New York, United States

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NCT07483294


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