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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lumateperone | Active Comparator | 42mg capsule, once a day for 8 weeks |
|
| Existing medication | Active Comparator | Existing medication reformulated in capsule, once or twice daily (as currently prescribed) for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumateperone 42 mg | Drug | Standard treatment with lumateperone |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in AES-C Score | 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. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in PANSS Score | Difference between the mean change in the PANSS score from baseline (V1) to Week 8 (V3) for 42 mg/day lumateperone vs. current antipsychotic medication. | 8 weeks |
| Change in BPRS Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shawn McNeil, MD | Contact | 318-675-7065 | shawn.mcneil@lsuhs.edu | |
| Stephanie Saunders, MA, CCRC | Contact | 318-675-7065 | stephanie.saunders@lsuhs.edu |
| Name | Affiliation | Role |
|---|---|---|
| Shawn McNeil, MD | LSU Health Shreveport | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LSU Health Shreveport | Recruiting | Shreveport | Louisiana | 71101 | United States |
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| ID | Term |
|---|---|
| D053609 | Lethargy |
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C000705749 | lumateperone |
| D018967 | Risperidone |
| D000077152 | Olanzapine |
| D000069348 | Quetiapine Fumarate |
| C092292 | ziprasidone |
| D000068180 | Aripiprazole |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Compare lumateperone treatment with existing medication
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| Risperidone 2 mg | Drug | Standard treatment with other antipsychotic drugs |
|
|
Difference between the mean change in the BPRS (Brief Psychiatric Rating Scale) score from baseline (V1) to Week 8 (V3) for 42 mg/day lumateperone vs. current antipsychotic medication.
| 8 weeks |
| Correlations between AES-C and PANSS Scores | Correlation between the AES-C score at Week 8 (V3) and negative symptoms score from PANSS at Week 8 (V3) for 42 mg/day lumateperone in comparison to current antipsychotic medication. | 8 weeks |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001569 |
| Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D010879 | Piperazines |
| D015363 | Quinolones |
| D011804 | Quinolines |