Phase
Condition
Schizophrenia And Schizoaffective Disorders (Pediatric)
Psychosis
Tourette's Syndrome
Treatment
Lumateperone 42 mg
Risperidone 2 mg
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female subjects between the ages of 18-65 that have been diagnosed withSchizophrenia, Schizoaffective Disorder or Schizophrenia Spectrum and OtherPsychotic 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 allscheduled evaluations, and likely to be compliant and complete all requiredassessments.
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 usemedically acceptable forms of birth control, which includes abstinence, while beingtreated 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 beconducted in English.
Must be willing to take and pass a urine drug screen with a negative result in orderto rule out psychotic symptoms due to drugs of abuse.
Exclusion
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 intercurrentillness that would, in the opinion of the Investigator, preclude studyparticipation.
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/apathyassessments, in the view of the investigator.
A diagnosis of Parkinson's disease.
Study Design
Study Description
Connect with a study center
LSU Health Shreveport
Shreveport, Louisiana 71101
United StatesActive - Recruiting

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