NCT06482554

Lumateperone for the Improvement of Apathy in Patients With Psychotic Symptoms.

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Louisiana State University Health Sciences Center Shreveport · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is looking to determine if Lumateperone improves motivation in patients with schizophrenia or schizoaffective disorders who show high levels of apathy as judged by AES-C-Apathy (Apathy Evaluation Scale - Clinician - Apathy) assessment and to examine a possible correlation between improvement in apathy scores and changes in elements of the PANSS (Positive and Negative Syndrome Scale) due to treatment with Lumateperone.

Detailed description

1. To determine if Lumateperone improves motivation in patients with schizophrenia or schizoaffective disorders who show high levels of apathy as judged by AES-C-Apathy assessment. 2. To examine a possible correlation between improvement in apathy scores and changes in elements of the PANSS (Positive and Negative Syndrome Scale) due to treatment with Lumateperone.

Conditions

• Apathy
• Schizophrenia
• Schizophrenia; Psychosis

Interventions

Type	Name	Description
DRUG	Lumateperone 42 mg	Standard treatment with lumateperone
DRUG	Risperidone 2 mg	Standard treatment with other antipsychotic drugs

Timeline

• Start date: 2024-06-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2024-07-01
• Last updated: 2024-07-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study