Cerebellum-based Imaging Neural Markers for Antipsychotic Response (CINEMA)

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

This study plans to collect 120 patients with first-episode psychosis. Participants will receive multimodal MRI scans (naturalistic fMRI, structural, diffusional) and comprehensive clinical assessments at baseline, and subsequently be treated with either risperidone or aripiprazole for 12 weeks. Clinical assessments for psychotic symptoms will be followed multiple times during the treatment until the 12th week. Data analysis will be conducted at the Psychiatric Research Unit of the Zucker Hillside Hospital.

Study Overview

• Status: Recruiting
• Conditions: Psychosis; Acute
• Intervention / Treatment: Drug: risperidone; Drug: aripiprazole

Detailed Description

This study plans to collect 120 patients with first-episode psychosis. Participants will receive multimodal MRI scans (naturalistic fMRI, structural, diffusional) and comprehensive clinical assessments at baseline, and subsequently be treated with either risperidone or aripiprazole for 12 weeks. Clinical assessments for psychotic symptoms will be followed multiple times during the treatment until the 12th week. Data analysis will be conducted at the Psychiatric Research Unit of the Zucker Hillside Hospital.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Hengyi Cao; Phone Number: 718-470-5913; Email: hcao2@northwell.edu
• Study Contact Backup: Name: Juan Gallego; Phone Number: 718-470-4588; Email: jgallego@northwell.edu

Study Locations

• United States
  • New York
    • Glen Oaks, New York, United States, 11004
      • Recruiting
      • Zucker Hillside Hospital
      • Contact: Taylor Marzouk; Phone Number: 718-470-8905; Email: tmarzouk@northwell.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

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

Description

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 15 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Drug; Open label drugs	Drug: risperidone; standard treatment, non-randomized; Drug: aripiprazole; standard treatment, non-randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cerebellar-cortical functional connectivity	To investigate the performance of cerebellar-cortical functional connectivity in prediction of antipsychotic response	July 2025 - December 2029
Cerebellar-cortical structural connectivity	To investigate the performance of cerebellar white matter microstructures in prediction of antipsychotic response	July 2025 - December 2029

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cerebellar structural-functional integration	To investigate the performance of integrated structural and functional connectivity in prediction of antipsychotic response	July 2025 - December 2029

Collaborators and Investigators

• Sponsor: Northwell Health
• Collaborators: National Institute of Mental Health (NIMH)

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2025
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): June 1, 2030

Study Registration Dates

• First Submitted: March 16, 2026
• First Submitted That Met QC Criteria: March 16, 2026
• First Posted (Actual): March 19, 2026

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Psychotic Disorders; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pyrimidines; Pyrimidinones; Quinolones; Quinolines; Piperazines; Aripiprazole; Risperidone
• Other Study ID Numbers: 25-0198; R01MH137501 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes