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Lumateperone for the Improvement of Apathy in Patients With Psychotic Symptoms.
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.
Details
| Lead sponsor | Louisiana State University Health Sciences Center Shreveport |
|---|---|
| Phase | Phase 3 |
| Status | RECRUITING |
| Enrolment | 80 |
| Start date | 2024-06 |
| Completion | 2026-12 |
Conditions
- Apathy
- Schizophrenia
- Schizophrenia; Psychosis
Interventions
- Lumateperone 42 mg
- Risperidone 2 mg
Primary outcomes
- Change in AES-C Score — 8 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.
Countries
United States