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Lumateperone for Schizophrenia

Phase 3
Recruiting
Led By Shawn McNeil, MD
Research Sponsored by Louisiana State University Health Sciences Center Shreveport
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female subjects between the ages of 18-65 diagnosed with Schizophrenia, Schizoaffective Disorder, or Schizophrenia Spectrum and Other Psychotic Disorders
Willing to take and pass a urine drug screen with a negative result
Must not have
Pregnant or female with no pregnancy prevention measures
Intellectual disability or cognitive impairment affecting assessments
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial aims to see if Lumateperone can help patients with schizophrenia or schizoaffective disorders who have low motivation. They will use a test to measure apathy levels and see if there

Who is the study for?
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.
What is being tested?
The study tests if Lumateperone (42 mg) can improve motivation compared to Risperidone (2 mg) in patients with schizophrenia-related apathy. It also looks at how changes in motivation might relate to changes in the PANSS scores, which measure different symptoms of schizophrenia.
What are the potential side effects?
While not specified here, common side effects for antipsychotics like Lumateperone may include drowsiness, weight gain, dry mouth, restlessness and gastrointestinal issues. Each person's reaction to medication can vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18-65 years old and have been diagnosed with Schizophrenia or a related disorder.
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I am willing to undergo and can pass a drug test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant and am using birth control.
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I have an intellectual disability or cognitive issues that affect my ability to participate in assessments.
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I am taking more than one antipsychotic medication.
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I am on a long-acting injection for psychosis.
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I have been diagnosed with dementia.
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I have been diagnosed with Parkinson's disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in AES-C Score
Secondary study objectives
Change in BPRS Score
Change in PANSS Score
Correlations between AES-C and PANSS Scores

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Group I: Existing medicationActive Control1 Intervention
Existing medication reformulated in capsule, once or twice daily (as currently prescribed) for 8 weeks
Group II: LumateperoneActive Control1 Intervention
42mg capsule, once a day for 8 weeks

Find a Location

Who is running the clinical trial?

Louisiana State University Health Sciences Center ShreveportLead Sponsor
49 Previous Clinical Trials
17,319 Total Patients Enrolled
2 Trials studying Schizophrenia
16 Patients Enrolled for Schizophrenia
Shawn McNeil, MDPrincipal InvestigatorLSU Health Shreveport
~53 spots leftby Dec 2026
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