Cerebellum-based Imaging Neural Markers for Antipsychotic Response

NCT07483294 | Recruiting

• 2 other identifiers: 25-0198R01MH137501
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psychosis; Acute

Outcome Measures

Primary Outcomes (2)

• Cerebellar-cortical functional connectivity

  To investigate the performance of cerebellar-cortical functional connectivity in prediction of antipsychotic response

  2025-2029

• Cerebellar-cortical structural connectivity

  To investigate the performance of cerebellar white matter microstructures in prediction of antipsychotic response

  2025-2029

Secondary Outcomes (1)

• Cerebellar structural-functional integration

  2025-2029

Interventions

Risperidone DRUG

Naturalistic treatment

Also known as: Aripiprazole

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwell Health: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Zucker Hillside Hospital

Glen Oaks, New York, 11004, United States

RECRUITING

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Risperidone; Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Hengyi Cao

CONTACT

718-470-5913; hcao2@northwell.edu

Juan Gallego

CONTACT

718-470-4588; jgallego@northwell.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 19, 2026
• Study Start: November 1, 2025
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): June 1, 2030
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

US (1)