Relationship Between Efficacy of Lumateperone and Brain Glutamate and Dopamine

Phase 4

Terminated

• Conditions: Psychosis
• Interventions: Drug: Lumateperone; Drug: Risperidone

• Registration Number: NCT05890768
• Lead Sponsor: University of New Mexico

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 t...

Detailed Description

Efficacy. To examine the differential relationships between antipsychotic efficacy and changes in central dopaminergic and glutamatergic metabolism in lumateperone and risperidone treated early psychosis patients. Hypothesis 1a). Lumateperone efficacy will be directly related to both striatal neuromelanin and medial cingulate glutamate changes. Hypothesis 1b...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2023-02-22
• Study Start: 2023-05-11
• Study First Submitted QC: 2023-05-25
• Study First Posted: 2023-06-06
• Primary Completion: 2024-02-28
• Study Completion: 2024-02-28
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-10
• Last Update Posted: 2024-06-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lumateperone	Lumateperone	Lumateperone 42 mg capsule 1 PO QD for 6 weeks
Risperidone	Risperidone	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.

Primary Outcome Measures

Name	Time	Method
Positive symptoms	6 weeks	Positive Scale, Negative Scale, and General Psychopathology Scale (PANSS) positive symptoms. Scale: min 1 to max 7; higher score is worse outcome.

Secondary Outcome Measures

Name	Time	Method
Correlation between weight gain and blood sugar	6 weeks	Weight gain and changes in fasting blood sugar
Correlation between positive symptoms and brain dopamine	6 weeks	Positive Scale, Negative Scale, and General Psychopathology Scale (PANSS, Scale: min 1 to max 7; higher score is worse outcome.) and brain neuromelanin
Correlation between circular RNAs and positive symptoms	6 weeks	Positive Scale, Negative Scale, and General Psychopathology Scale (PANSS, Scale: min 1 to max 7; higher score is worse outcome.) and circular RNAs in blood
Correlation between positive symptoms and brain glutamate	6 weeks	Positive Scale, Negative Scale, and General Psychopathology Scale (PANSS; Scale: min 1 to max 7; higher score is worse outcome.) and brain spectroscopy glutamate
Extrapyramidal symptoms	6 weeks	Simpson-Angus Scale (SAS). Scale: min 1 to max 5; higher score is worse outcome.
Correlation between extrapyramidal symptoms and brain dopamine	6 weeks	Simpson-Angus Scale (SAS, Scale: min 1 to max 5; higher score is worse outcome.) and brain neuromelanin
Correlation between SAS and prolactin	6 weeks	Simpson-Angus Scale (SAS, Scale: min 1 to max 5; higher score is worse outcome.) and serum prolactin
Correlation between weight gain and lipids	6 weeks	Weight gain and changes in cholesterol and triglycerides

Trial Locations

Locations (1)

University of New Mexico; 🇺🇸 Albuquerque, New Mexico, United States