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
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
Treatments tested in this trial
- risperidone
- aripiprazole
Treatment groups
120 Participants
are divided into 1 treatment groupSponsors and collaborators
Northwell Health
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov