Lumateperone for Schizophrenia
Trial Summary
Will I have to stop taking my current medications?
The trial requires that your current medication regimen be stable for at least 30 days before joining. If you're taking more than one antipsychotic or a long-acting injectable for psychotic symptoms, you may need to adjust your medications.
What data supports the effectiveness of the drug Lumateperone for treating schizophrenia?
Is lumateperone safe for humans?
Lumateperone, also known as Caplyta, has been shown to be generally safe in humans, with most side effects being mild, such as drowsiness and dry mouth. Studies found that it has a favorable safety profile compared to other antipsychotics, with fewer issues like weight gain and movement problems.12356
What makes the drug Lumateperone unique for treating schizophrenia?
Lumateperone is unique because it is a first-in-class drug that simultaneously affects serotonin, dopamine, and glutamate pathways, which may help with a wide range of schizophrenia symptoms. It also has a favorable side effect profile, particularly regarding weight gain, compared to other antipsychotic medications.23578
What is the purpose of this trial?
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.
Research Team
Shawn McNeil, MD
Principal Investigator
LSU Health Shreveport
Eligibility Criteria
This trial is for individuals with schizophrenia or schizoaffective disorders who are notably apathetic. Participants must show high levels of apathy as measured by a specific assessment (AES-C-Apathy). The study excludes details on specific inclusion and exclusion criteria, but these typically involve age, health status, and other medications being taken.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Lumateperone or existing medication for 8 weeks to assess improvement in apathy and correlation with PANSS scores
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Lumateperone
Lumateperone is already approved in United States for the following indications:
- Schizophrenia
- Bipolar I or II disorder (bipolar depression)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Louisiana State University Health Sciences Center Shreveport
Lead Sponsor