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

Launched by LOUISIANA STATE UNIVERSITY HEALTH SCIENCES CENTER SHREVEPORT · Jun 26, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Lumateperone to see if it can help improve motivation in people with schizophrenia or schizoaffective disorders who are experiencing high levels of apathy, which is a lack of interest or motivation. Researchers want to find out if improvements in motivation are linked to changes in other symptoms of psychosis, as measured by specific tests. The trial is currently looking for participants aged 18 to 65 who have been diagnosed with these conditions and meet certain health criteria.

To participate, individuals must have specific scores indicating significant symptoms related to their condition and must be stable on their current treatment for at least 30 days. Participants will be asked to take the medication and attend regular evaluations to monitor their progress. It's important for potential participants to know that they will need to pass a urine drug test and that women of childbearing age must not be pregnant and should use birth control during the study. This trial aims to better understand how Lumateperone might help those struggling with apathy related to their mental health conditions.

Gender

ALL

Eligibility criteria

• Inclusion 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.
• Exclusion Criteria:
• • 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.