Cerebellum-based Imaging Neural Markers for Antipsychotic... | NCT07483294

Studies
Cerebellum-based Imaging Neural Markers for Antipsychotic Response

NCT07483294

Sponsor

Northwell Health

Status

Recruiting

Last Update Posted

May 26, 2026Actual

Enrollment

120Estimated

Phase

Phase 4

Conditions

Psychosis; Acute

Interventions

risperidone
aripiprazole

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01MH137501	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2025Actual

Primary Completion Date

Dec 1, 2029Estimated

Completion Date

Jun 1, 2030Estimated

First Submitted Date

Mar 16, 2026

First Submission Date that Met QC Criteria

Mar 16, 2026

First Posted Date

Mar 19, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 21, 2026

Last Update Posted Date

May 26, 2026Actual

Name	Class
National Institute of Mental Health (NIMH)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Drug	Experimental	Open label drugs	Drug: risperidone Drug: aripiprazole

Interventions

Name	Type	Description	Arm Group Labels	Other Names
risperidone	Drug	standard treatment, non-randomized	Drug
aripiprazole

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

40 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hengyi Cao	Contact	718-470-5913		hcao2@northwell.edu
Juan Gallego	Contact	718-470-4588		jgallego@northwell.edu

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zucker Hillside Hospital	Recruiting	Glen Oaks	New York	11004	United States

ID	Term
D011618	Psychotic Disorders

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

Intervention Browse Module

MeSH Terms

ID	Term
D018967	Risperidone
D000068180	Aripiprazole

Ancestor Terms

ID	Term
D011744	Pyrimidinones
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided