RecruitingPhase 3NCT06482554

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


Sponsor

Louisiana State University Health Sciences Center Shreveport

Enrollment

80 participants

Start Date

Jun 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing lumateperone — an atypical antipsychotic medication — to see whether it can reduce apathy (a lack of motivation and emotional engagement) in people who have schizophrenia or a related psychotic disorder. Apathy is a common and debilitating symptom that is often undertreated. **You may be eligible if...** - You are 18–65 years old - You have been diagnosed with schizophrenia, schizoaffective disorder, or a related psychotic disorder - You scored above a certain threshold on apathy and symptom rating scales at screening - You have been on a stable treatment regimen for at least 30 days - You are not pregnant or breastfeeding (if applicable) **You may NOT be eligible if...** - Your symptoms are unstable or you recently changed medications - You have certain medical conditions that would make participation unsafe - You are unable to comply with all required assessments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLumateperone 42 mg

Standard treatment with lumateperone

DRUGRisperidone 2 mg

Standard treatment with other antipsychotic drugs


Locations(1)

LSU Health Shreveport

Shreveport, Louisiana, United States

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NCT06482554


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