Recruiting
Phase 3

Lumateperone

Sponsor:

Louisiana State University Health Sciences Center Shreveport

Code:

NCT06482554

Conditions

Apathy

Schizophrenia

Schizophrenia; Psychosis

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Lumateperone 42 mg

Risperidone 2 mg

Study Details

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.

Conditions

Apathy

Schizophrenia

Schizophrenia; Psychosis

Study ID

NCT06482554

Start date

Jun, 2024

Status verified date

Jun, 2024

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Lumateperone

42mg capsule, once a day for 8 weeks

active comparator: Existing medication

Existing medication reformulated in capsule, once or twice daily (as currently prescribed) for 8 weeks

Interventions

Lumateperone 42 mg

Standard treatment with lumateperone

Risperidone 2 mg

Standard treatment with other antipsychotic drugs

Primary outcome measure

  • Change in AES-C Score [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Shawn McNeil, MD

318-675-7065shawn.mcneil@lsuhs.edu

Stephanie Saunders, MA, CCRC

318-675-7065stephanie.saunders@lsuhs.edu

Locations

LSU Health Shreveport

Recruiting

Shreveport, Louisiana, United States, 71101

Contacts

Stephanie Saunders, MA, CCRC

318-675-7065stephanie.saunders@lsuhs.edu

Shawn McNeil, MD

318-675-7065shawn.mcneil@lsuhs.edu

Principal Investigator:

Shawn McNeil, MD

More Information

Sponsor

Louisiana State University Health Sciences Center Shreveport

Last update posted

Jul 1, 2024

Last verified

Jun, 2024

Keywords

  • Schizophrenia
  • Schizoaffective
  • Psychosis
  • Psychotic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Louisiana State University Health Sciences Center Shreveport on 2024-07-01.