RECRUITINGOBSERVATIONAL
Cerebellum-based Imaging Neural Markers for Antipsychotic Response
Cerebellar-cortical Circuitry and Prediction of Treatment Response in Early Psychosis
About This Trial
This study will investigate neural markers in the cerebellar-cortical circuitry that predict treatment response to antipsychotics in first-episode psychosis. A total of 120 patients diagnosed with a first-episode psychotic disorder will be recruited. All subjects receive naturalistic treatment with either risperidone or aripiprazole for 12 weeks, with dosage and titration followed by standard clinical care. A comprehensive clinical and neuroimaging assessments will be performed before and after treatment.
Who May Be Eligible (Plain English)
Who May Qualify:
- Diagnosis of a first-episode psychotic disorder including: schizophrenia, schizophreniform disorder, schizoaffective disorder, brief psychotic disorder, psychotic disorder NOS, bipolar disorder with psychosis, and major depressive disorder with psychosis;
- Current positive symptoms rated \> 3 (moderate) on one or more of the 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 16 to 40;
- Competent to sign willing to sign a consent form.
Who Should NOT Join This Trial:
- 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 willing to sign a consent form;
- Contraindications to antipsychotic monotherapy;
- Contraindications to MR imaging (e.g. pacemaker);
- Pregnancy by self report.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* Diagnosis of a first-episode psychotic disorder including: schizophrenia, schizophreniform disorder, schizoaffective disorder, brief psychotic disorder, psychotic disorder NOS, bipolar disorder with psychosis, and major depressive disorder with psychosis;
* Current positive symptoms rated \> 3 (moderate) on one or more of the 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 16 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.
Treatments Being Tested
DRUG
Risperidone
Naturalistic treatment
Locations (1)
Zucker Hillside Hospital
Glen Oaks, New York, United States