Lumateperone for the Improvement of Apathy in Patients With Psychotic Symptoms.
Louisiana State University Health Sciences Center Shreveport
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.
Description
1. 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 assessment. 2. 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
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
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 t…
Interventions
- DrugLumateperone 42 mg
Standard treatment with lumateperone
- DrugRisperidone 2 mg
Standard treatment with other antipsychotic drugs
Location
- LSU Health ShreveportShreveport, Louisiana