Recruiting

Risperidone & Aripiprazole

Sponsor:

Northwell Health

Code:

NCT07483294

Conditions

Psychosis; Acute

Eligibility Criteria

Sex: All

Age: 15 - 40

Healthy Volunteers: Not accepted

Interventions

risperidone

aripiprazole

Study Details

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.

Conditions

Psychosis; Acute

Study ID

NCT07483294

Start date

Nov 1, 2025

Status verified date

Mar, 2026

Completion date

Jun 1, 2030

Anticipated

Primary completion date

Dec 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15 - 40

Healthy Volunteers: Not accepted

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 Design

Enrollment

120 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Drug

Open label drugs

Interventions

risperidone

standard treatment, non-randomized

aripiprazole

standard treatment, non-randomized

Primary outcome measure

  • Cerebellar-cortical functional connectivity [ Time Frame: July 2025 - December 2029 ]
  • Cerebellar-cortical structural connectivity [ Time Frame: July 2025 - December 2029 ]

Central Contacts and Locations

Central contacts

Hengyi Cao

718-470-5913hcao2@northwell.edu

Juan Gallego

718-470-4588jgallego@northwell.edu

Locations

Zucker Hillside Hospital

Recruiting

Glen Oaks, New York, United States, 11004

Contacts

Taylor Marzouk

718-470-8905tmarzouk@northwell.edu

More Information

Sponsor

Northwell Health

Last update posted

May 26, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northwell Health on 2026-05-26.