Clinical trial NCT06482554: Lumateperone for the Improvement of Apathy in Patients With Psychotic Symptoms.
Official title: Lumateperone for the Improvement of Apathy in Patients With Psychotic Symptoms.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Apathy
Schizophrenia
Schizophrenia; Psychosis
Keywords: Schizophrenia
Schizoaffective
Psychosis
Psychotic
Lead sponsor: Louisiana State University Health Sciences Center Shreveport
Sponsor class: OTHER
First posted: 2024-07-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Compare lumateperone treatment with existing medication
Primary purpose: TREATMENT

Brief 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.

Detailed 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 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.

Primary outcomes:
measure: Change in AES-C Score
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in PANSS Score
timeFrame: 8 weeks
measure: Change in BPRS Score
timeFrame: 8 weeks
measure: Correlations between AES-C and PANSS Scores
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Shreveport
country: United States
facility: LSU Health Shreveport
state: Louisiana
Study officials:
affiliation: LSU Health Shreveport
name: Shawn McNeil, MD
role: PRINCIPAL_INVESTIGATOR
References: