NCT07483294

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
48mo left

Started Nov 2025

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Nov 2025Jun 2030

Study Start

First participant enrolled

November 1, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 19, 2026

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2030

Last Updated

May 26, 2026

Status Verified

March 1, 2026

Enrollment Period

4.1 years

First QC Date

March 16, 2026

Last Update Submit

May 21, 2026

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

    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 Outcomes (1)

  • Cerebellar structural-functional integration

    July 2025 - December 2029

Study Arms (1)

Drug

EXPERIMENTAL

Open label drugs

Drug: risperidoneDrug: aripiprazole

Interventions

risperidoneDRUG

standard treatment, non-randomized

Drug
aripiprazoleDRUG

standard treatment, non-randomized

Drug

Eligibility Criteria

Age15 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zucker Hillside Hospital

Glen Oaks, New York, 11004, United States

RECRUITING

MeSH Terms

Conditions

Psychotic Disorders

Interventions

RisperidoneAripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazinesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Central Study Contacts

Hengyi Cao

CONTACT

718-470-5913hcao2@northwell.edu

Juan Gallego

CONTACT

718-470-4588jgallego@northwell.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
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

May 26, 2026

Record last verified: 2026-03

Locations

US(1)