RECRUITING

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

Conditions

Apathy Schizophrenia Schizophrenia; Psychosis Schizoaffective Psychosis Psychotic

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-06

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06482554

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.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Shawn McNeil, MD

CONTACT

318-675-7065

shawn.mcneil@lsuhs.edu

Stephanie Saunders, MA, CCRC

CONTACT

318-675-7065

stephanie.saunders@lsuhs.edu

Principal Investigator

Shawn McNeil, MD

PRINCIPAL_INVESTIGATOR

LSU Health Shreveport

Study Locations (Sites)

LSU Health Shreveport

Shreveport, Louisiana, 71101

United States

Collaborators and Investigators

Sponsor: Louisiana State University Health Sciences Center Shreveport

Shawn McNeil, MD, PRINCIPAL_INVESTIGATOR, LSU Health Shreveport

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06

Study Completion Date2026-12

Study Record Updates

Study Start Date2024-06

Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

Schizophrenia
Schizoaffective
Psychosis
Psychotic

Additional Relevant MeSH Terms

Apathy
Schizophrenia
Schizophrenia; Psychosis