Brain Imaging and Antipsychotic Response in First-Episode Psychosis

This study is looking at how the brain's cerebellum (a part of the brain that helps with movement and balance) is connected to other brain areas in people experiencing their first episode of psychosis. Researchers want to see if these connections change when people are treated with either risperidone or aripiprazole, two common medications for psychosis. You might be able to join if you are 15 to 40 years old and have been diagnosed with a first-episode psychotic disorder, such as schizophrenia or bipolar disorder with psychosis, and are currently experiencing moderate positive symptoms. The study aims to enroll 120 participants. The study's success will be measured by changes in these brain connections over time.

Study design
This interventional study plans to enroll 120 participants. You will receive either risperidone or aripiprazole, which are standard treatments.
What's involved
You will have multimodal MRI scans (brain imaging) and clinical assessments at the start of the study. You will then receive treatment for 12 weeks, with clinical assessments for psychotic symptoms multiple times during this period.
Compensation
Not stated in the trial record.
Follow-up
Your brain connectivity will be measured between July 2025 and December 2029, indicating a long-term follow-up period after the 12-week treatment.

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NCT07483294

Cerebellum-based Imaging Neural Markers for Antipsychotic Response

Recruiting
PHASE4Ages 15–40Interventional
Northwell Health
~120 participants
Updated 2026-05-26 on ClinicalTrials.gov
What's tested:risperidonearipiprazole

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cerebellar-cortical functional connectivity
Measured over July 2025 - December 2029
+1 more outcome measured
Psychosis; Acute
1 sites across 1 states
New York1

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Eligibility criteria

Inclusion

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

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.
  • Cerebellar-cortical functional connectivityJuly 2025 - December 2029

    To investigate the performance of cerebellar-cortical functional connectivity in prediction of antipsychotic response

  • Cerebellar-cortical structural connectivityJuly 2025 - December 2029

    To investigate the performance of cerebellar white matter microstructures in prediction of antipsychotic response