Psychosis; Acute
Conditions
Brief summary
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
DRUGrisperidone
standard treatment, non-randomized
DRUGaripiprazole
standard treatment, non-randomized
Sponsors
Northwell Health
National Institute of Mental Health (NIMH)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cerebellar-cortical functional connectivity | July 2025 - December 2029 | To investigate the performance of cerebellar-cortical functional connectivity in prediction of antipsychotic response |
| Cerebellar-cortical structural connectivity | July 2025 - December 2029 | To investigate the performance of cerebellar white matter microstructures in prediction of antipsychotic response |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cerebellar structural-functional integration | July 2025 - December 2029 | To investigate the performance of integrated structural and functional connectivity in prediction of antipsychotic response |
Countries
United States
Contacts
CONTACTHengyi Cao
CONTACTJuan Gallego
Outcome results
None listed