Using Lumateperone to improve motivation in patients with schizophrenia and psychosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of Lumateperone in enhancing motivation among patients diagnosed with schizophrenia or schizoaffective disorders who exhibit significant apathy. Participants will be assessed using the Apathy Evaluation Scale - Clinician to measure levels of apathy before and after treatment. Additionally, the study will explore the relationship between changes in apathy scores and the Positive and Negative Syndrome Scale scores, providing insights into the broader impact of Lumateperone on psychotic symptoms.

Why it matters

Who can join: the full rules

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.

Where it's running

• LSU Health Shreveport
  Shreveport, Louisiana, United States Recruiting

Study contacts

• Principal investigator: Shawn McNeil, MD — LSU Health Shreveport
• Study coordinator: Shawn McNeil, MD
• Email: shawn.mcneil@lsuhs.edu
• Phone: 318-675-7065

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.