Relationship Between Efficacy of Lumateperone and Brain Glutamate and Dopamine

• Status: Recruiting
• Trial end date: 2026-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will examine the differential relationships between antipsychotic efficacy and changes in dopaminergic and glutamatergic brain metabolism in lumateperone and risperidone treated early psychosis patients. Baseline glutamate and dopamine brain scans, and symptom severity measures will be collected, followed by repeated measures at 6 weeks. Half of the early psychosis patients will be treated with lumateperone, half with risperidone. Healthy control subejcts will also be examined once.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of New Mexico
• Treatments: Risperidone

Criteria

Patient group:

• Inclusion:

1. Diagnosis of DSM-5 schizophrenia, bipolar-I mania and mixed episodes with psychotic features, schizophreniform, schizoaffective, delusional, and unspecified schizophrenia spectrum and other psychotic disorders, established with SCID-P for DSM-5;

2. age between 18 and 40 years old;

3. antipsychotic exposure no greater than 50 mg of olanzapine equivalents (Gardner et al. AJP, 2010) in the 7 days previous to baseline assessments.

• Exclusion:

1. neurological disorder, intellectual disability, history of severe head trauma (unconciousness >10 min);

2. diagnosis of active substance use disorder (except for nicotine and cannabinoids [cannabinoids use is a risk factor for psychosis]).

Healthy Volunteers (HV) group:

• Inclusion:

a) age between 18 and 40 years old.

• Exclusion:

1. current or past psychiatric disorder (assessed with the SCID-NP; subjects with past history of anxiety or depressive disorders receiving no active treatment in the previous 12 months may be included);

2. past or current diagnosis of neurological disorder, history of severe head trauma or diagnosis of active substance use disorder (except for nicotine or cannabinoids); and c) history of a psychotic disorder in first-degree relatives.