Apathy, Schizophrenia, Schizophrenia; Psychosis
Conditions
Keywords
Schizophrenia, Schizoaffective, Psychosis, Psychotic
Brief summary
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.
Detailed description
1. 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 assessment. 2. 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.
Interventions
Standard treatment with lumateperone
DRUGRisperidone 2 mg
Standard treatment with other antipsychotic drugs
Sponsors
Louisiana State University Health Sciences Center Shreveport
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Compare lumateperone treatment with existing medication
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in PANSS Score | 8 weeks | 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. |
| Change in BPRS Score | 8 weeks | 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. |
| Correlations between AES-C and PANSS Scores | 8 weeks | 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. |
Countries
United States
Contacts
Primary ContactShawn McNeil, MD
Backup ContactStephanie Saunders, MA, CCRC
Outcome results
None listed