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

Description

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

Apathy, Schizophrenia, Schizophrenia; Psychosis

Study Overview

Study Details

Study overview

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.

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

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

Condition
Apathy
Intervention / Treatment

-

Contacts and Locations

Shreveport

LSU Health Shreveport, Shreveport, Louisiana, United States, 71101

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Male or female subjects between the ages of 18-65 that have been diagnosed with Schizophrenia, Schizoaffective Disorder or Schizophrenia Spectrum and Other Psychotic Disorders.
  • * A BPRS score \> 35 at the screening visit.
  • * An AES-C score \> 32 at the screening visit.
  • * If the subject is on a therapeutic regimen, that regimen must be stable for at least 30 days prior to screening. A therapeutic regimen may include medication, supplements, and/or probiotics.
  • * In the opinion of the Investigator, the subject is able to participate in all scheduled evaluations, and likely to be compliant and complete all required assessments.
  • * Female subjects of childbearing potential must not be pregnant or breast-feeding. Female subjects of childbearing potential must have a negative urine pregnancy test. Subjects of childbearing or child-fathering potential must be willing to use medically acceptable forms of birth control, which includes abstinence, while being treated on this study and for 30 days after the last dose of study drug.
  • * Must speak and understand English, as the consent and all evaluations will be conducted in English.
  • * Must be willing to take and pass a urine drug screen with a negative result in order to rule out psychotic symptoms due to drugs of abuse.
  • * A BPRS score \< 35 at the screening visit.
  • * An AES-C score \< 32 at the screening visit.
  • * Have any clinically significant medical condition or an unstable intercurrent illness that would, in the opinion of the Investigator, preclude study participation.
  • * Are currently taking more than one antipsychotic medication.
  • * Are currently taking a long-acting injectable medication for psychotic symptoms.
  • * Have a substance use disorder or show a positive drug screen for stimulants.
  • * Are pregnant or of female sex with no evidence of measures for pregnancy prevention.
  • * Presence of dementia.
  • * Intellectual disability or cognitive impairment that would affect the symptom/apathy assessments, in the view of the investigator.
  • * A diagnosis of Parkinson's disease.

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Louisiana State University Health Sciences Center Shreveport,

Shawn McNeil, MD, PRINCIPAL_INVESTIGATOR, LSU Health Shreveport

Study Record Dates

2026-12