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NCT Number: NCT07483294

Cerebellum-based Imaging Neural Markers for Antipsychotic Response

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.

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Key information

Age range

15 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Zucker Hillside Hospital

Glen Oaks, New York, 11004, United States

Location status: Recruiting

Location contact

Taylor Marzouk

CONTACT

[email protected]

718-470-8905

About this study

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

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Risperidone

Drug

standard treatment, non-randomized

Aripiprazole

Drug

standard treatment, non-randomized

Primary outcomes

  1. Cerebellar-cortical functional connectivity

    Time frame: July 2025 - December 2029

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

  2. Cerebellar-cortical structural connectivity

    Time frame: July 2025 - December 2029

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

Secondary outcomes

  1. Cerebellar structural-functional integration

    Time frame: July 2025 - December 2029

    To investigate the performance of integrated structural and functional connectivity in prediction of antipsychotic response

Study contacts

Contact information is provided by the study sponsor or research team.

Hengyi Cao

CONTACT

[email protected]

718-470-5913

Juan Gallego

CONTACT

[email protected]

718-470-4588

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Cerebellar-cortical Circuitry and Prediction of Treatment Response in Early Psychosis

Acronym: CINEMA

Important dates

Study start
2025
Primary completion
2029
Study completion
2030
First posted
Mar 19, 2026
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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