Health TrialsbyHealthPanel

Cerebellum-based Imaging Neural Markers for Antipsychotic Response

ConditionPsychosis; Acute
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age15-40
SponsorNorthwell Health

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • risperidone

    Drug

    standard treatment, non-randomized

  • aripiprazole

    Drug

    standard treatment, non-randomized

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: DrugExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Cerebellar-cortical functional connectivity

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

Time frame
July 2025 - December 2029
2

Cerebellar-cortical structural connectivity

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

Time frame
July 2025 - December 2029

Secondary outcomes

1

Cerebellar structural-functional integration

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

Time frame
July 2025 - December 2029

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwell Health

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov
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