Cerebellum-based Imaging Neural Markers for Antipsychotic Response
Recruiting · NCT07483294 · Interventional (participants receive a specific treatment) · Lead sponsor: Northwell Health
View the official record on ClinicalTrials.gov →Interventions studied
What this trial 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. 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 take part
Age range
15 Years to 40 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed across 1 US state.
- Zucker Hillside Hospital - Glen Oaks, New York, United States