Relationship Between Efficacy of Lumateperone and Brain Glutamate and Dopamine

NCT05890768 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 22-396
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psychosis

Outcome Measures

Primary Outcomes (1)

• Positive symptoms

  Positive Scale, Negative Scale, and General Psychopathology Scale (PANSS) positive symptoms. Scale: min 1 to max 7; higher score is worse outcome.

  6 weeks

Secondary Outcomes (8)

• Extrapyramidal symptoms

  6 weeks

• Correlation between positive symptoms and brain glutamate

  6 weeks

• Correlation between positive symptoms and brain dopamine

  6 weeks

• Correlation between extrapyramidal symptoms and brain dopamine

  6 weeks

• Correlation between SAS and prolactin

  6 weeks

Study Arms (2)

Lumateperone

EXPERIMENTAL

Lumateperone 42 mg capsule 1 PO QD for 6 weeks

Drug: Lumateperone

Risperidone

ACTIVE COMPARATOR

Risperidone starts 1 mg capsule PO QD for 1 week; then titrated blindly per clinical response and tolerability up to: 2 mg capsule QD starting in week 2; up to 3 mg capsule QD starting in week 3; and up to 4 mg capsule QD starting in week 4. Total risperidone exposure of 6 weeks.

Drug: Risperidone

Interventions

Lumateperone DRUG

FDA approved antipsychotic drug

Also known as: Caplyta

Lumateperone

Risperidone DRUG

FDA approved antipsychotic drug

Also known as: Risperdol

Risperidone

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• age between 18 and 40 years old;
• antipsychotic exposure no greater than 50 mg of olanzapine equivalents (Gardner et al. AJP, 2010) in the 7 days previous to baseline assessments.

You may not qualify if:

• neurological disorder, intellectual disability, history of severe head trauma (unconciousness \>10 min);
• diagnosis of active substance use disorder (except for nicotine and cannabinoids \[cannabinoids use is a risk factor for psychosis\]).
• Healthy Volunteers (HV) group:
• a) age between 18 and 40 years old.
• 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);
• 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.

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87106, United States

Location

Related Publications (32)

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MeSH Terms

Conditions

Psychotic Disorders

Interventions

lumateperone; Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Juan Bustillo, MD

  UNM HSC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: June 6, 2023
• Study Start: May 11, 2023
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: March 5, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)