NCT07483294 · Northwell Health
Cerebellum-based Imaging Neural Markers for Antipsychotic Response
(CINEMA)
What this study is about
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.
View original scientific 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Glen Oaks, New York
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 26, 2026 · Source of record for eligibility and locations