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Lumateperone for Apathy in Schizophrenia

This study is exploring whether Lumateperone 42 mg can help improve motivation (apathy) in people with schizophrenia or schizoaffective disorders. You might be able to join if you are between 18 and 65 years old, have a diagnosis of schizophrenia or a related psychotic disorder, and show high levels of apathy. Researchers will compare Lumateperone to Risperidone 2 mg, another antipsychotic medication. Success in this study would mean a significant improvement in apathy scores, measured after 8 weeks. The study is currently unclear on its recruitment status and plans to enroll 80 participants.

Study design
This study is interventional and plans to enroll 80 participants. It compares Lumateperone 42 mg to Risperidone 2 mg.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Apathy will be measured at 8 weeks after starting treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06482554

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

Recruiting
PHASE3Ages 18–65InterventionalTreatment
Louisiana State University Health Sciences Center Shreveport
~80 participants
Updated 2024-07-01 on ClinicalTrials.gov
What's tested:Lumateperone 42 mgRisperidone 2 mg

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in AES-C Score
Measured over 8 weeks

Conditions

Apathy
Schizophrenia
Schizophrenia; Psychosis

Explore related trials

PsychosisSchizoaffective DisorderSchizophrenia

Where it's being run

1 sites across 1 states
Louisiana1

Study leadership

  • Shawn McNeil, MD · PRINCIPAL_INVESTIGATOR · LSU Health Shreveport

Who to contact

Shawn McNeil, MD
[email protected]
318-675-7065
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Change in AES-C Score8 weeks

    Difference between the mean change in the AES-C score from baseline (V1) to Week 8 (V3) for 42 mg/day lumateperone vs. current antipsychotic medication.