Lumateperone for the Improvement of Apathy in Patients With Psychotic Symptoms.

NCT ID: NCT06482554

Last Updated: 2024-07-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-30
• Study Completion Date: 2026-12-31

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.

Conditions

Apathy; Schizophrenia; Schizophrenia; Psychosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Lumateperone

42mg capsule, once a day for 8 weeks

Group Type: ACTIVE_COMPARATOR

Lumateperone 42 mg

Intervention Type: DRUG

Standard treatment with lumateperone

Existing medication

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

Group Type: ACTIVE_COMPARATOR

Risperidone 2 mg

Intervention Type: DRUG

Standard treatment with other antipsychotic drugs

Interventions

Lumateperone 42 mg

Standard treatment with lumateperone

Intervention Type: DRUG

Risperidone 2 mg

Standard treatment with other antipsychotic drugs

Intervention Type: DRUG

Other Intervention Names

Lumateperone; olanzapine; quetiapine; ziprasidone; aripiprazole

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Louisiana State University Health Sciences Center Shreveport

OTHER

Sponsor Role: lead

Responsible Party

Shawn McNeil

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shawn McNeil, MD

Role: PRINCIPAL_INVESTIGATOR

LSU Health Shreveport

Locations

LSU Health Shreveport

Shreveport, Louisiana, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Shawn McNeil, MD

Role: CONTACT

shawn.mcneil@lsuhs.edu

318-675-7065

Stephanie Saunders, MA, CCRC

Role: CONTACT

stephanie.saunders@lsuhs.edu

318-675-7065

Facility Contacts

Stephanie Saunders, MA, CCRC

Role: primary

stephanie.saunders@lsuhs.edu

318-675-7065

Shawn McNeil, MD

Role: backup

shawn.mcneil@lsuhs.edu

318-675-7065

Other Identifiers

STUDY00002212

Identifier Type: -

Identifier Source: org_study_id