Cerebellar imaging markers to predict antipsychotic response in first-episode psychosis

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

This will test whether cerebellar brain scans can predict how people with first-episode psychosis respond to 12 weeks of treatment with risperidone or aripiprazole.

Quick facts

• Study type: Observational
• Enrollment: 120 (estimated)
• Ages: 16 Years to 40 Years
• Sex: All
• Sponsor: Northwell Health (other)
• Locations: 1 site (Glen Oaks, New York)
• Trial ID: NCT07483294 on ClinicalTrials.gov

What this trial studies

The study will recruit 120 participants aged 16–40 with a first-episode psychotic disorder who have received eight weeks or less of antipsychotic treatment. Participants receive naturalistic clinical care with either risperidone or aripiprazole for 12 weeks while comprehensive clinical ratings and neuroimaging focused on cerebellar-cortical circuitry are collected at baseline and after treatment. Imaging and clinical data will be analyzed to identify cerebellar structural or connectivity markers that correlate with symptom response. The approach seeks biomarkers usable under standard-care conditions to inform individualized treatment choices.

Who should consider this trial

Good fit: Ideal candidates are people aged 16–40 with a first-episode psychotic disorder, moderate positive symptoms on the BPRS, antipsychotic exposure of eight weeks or less, and capacity to provide informed consent.

Not a fit: Patients with chronic or long-standing psychosis, serious neurological or endocrine disorders, active suicidal or homicidal risk, inability to complete MRI or clinical assessments, or who require medications with psychotropic effects are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this could help clinicians choose the most effective antipsychotic sooner by using cerebellar imaging to guide treatment and reduce trial-and-error.

How similar studies have performed: Some prior neuroimaging studies have linked brain connectivity measures to antipsychotic response, but cerebellum-centered biomarkers are relatively novel and not yet widely validated.

Eligibility criteria

Inclusion Criteria:

* Diagnosis of a first-episode psychotic disorder including: schizophrenia, schizophreniform disorder, schizoaffective disorder, brief psychotic disorder, psychotic disorder Not Otherwise Specified (NOS), bipolar disorder with psychosis, and major depressive disorder with psychosis;
* Current positive symptoms rated \> 3 (moderate) on one or more of the Brief Psychiatric Rating Scale (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 Criteria:

* 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.

Where this trial is running

Glen Oaks, New York

• Zucker Hillside Hospital — Glen Oaks, New York, United States (RECRUITING)

Study contacts

• Study coordinator: Hengyi Cao

Conditions: Psychosis, Acute