MedTrace Logo

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

NCT06482554 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-07-01

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Lumateperone 42 mg

Standard treatment with lumateperone

DRUG

Risperidone 2 mg

Standard treatment with other antipsychotic drugs

Sponsors & Collaborators

  • Louisiana State University Health Sciences Center Shreveport

    lead OTHER

Principal Investigators

  • Shawn McNeil, MD · LSU Health Shreveport

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-30
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06482554 on ClinicalTrials.gov