Cerebellar imaging markers to predict antipsychotic response in first-episode psychosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study will recruit 120 participants aged 16–40 with a first-episode psychotic disorder who have received eight weeks or less of antipsychotic treatment. Participants receive naturalistic clinical care with either risperidone or aripiprazole for 12 weeks while comprehensive clinical ratings and neuroimaging focused on cerebellar-cortical circuitry are collected at baseline and after treatment. Imaging and clinical data will be analyzed to identify cerebellar structural or connectivity markers that correlate with symptom response. The approach seeks biomarkers usable under standard-care conditions to inform individualized treatment choices.

Why it matters

Who can join: the full rules

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.

Where it's running

• Zucker Hillside Hospital
  Glen Oaks, New York, United States Recruiting

Study contacts

• Study coordinator: Hengyi Cao
• Email: hcao2@northwell.edu
• Phone: 718-470-5913

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.