Cerebellum-based Imaging Neural Markers for Antipsychotic Response
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: risperidone, aripiprazole.
- Who it may be relevant to
- Registry conditions: Psychosis; Acute. Basic parameters: 15 years — 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Cerebellar-cortical Circuitry and Prediction of Treatment Response in Early Psychosis
Overview
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
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.
Interventions
- Drug risperidone
standard treatment, non-randomized - Drug aripiprazole
standard treatment, non-randomized
Primary outcome measures
- Cerebellar-cortical functional connectivity [Time frame: July 2025 - December 2029]
- Cerebellar-cortical structural connectivity [Time frame: July 2025 - December 2029]
Secondary outcome measures (1)
- Cerebellar structural-functional integration [Time frame: July 2025 - December 2029]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Zucker Hillside Hospital — Glen Oaks
Identifiers
NCT: NCT07483294 · 25-0198 · R01MH137501