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

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.

Study Overview

• Status: Recruiting
• Conditions: Schizophrenia; Schizophrenia; Psychosis; Apathy
• Intervention / Treatment: Drug: Lumateperone 42 mg; Drug: Risperidone 2 mg

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Shawn McNeil, MD; Phone Number: 318-675-7065; Email: shawn.mcneil@lsuhs.edu
• Study Contact Backup: Name: Stephanie Saunders, MA, CCRC; Phone Number: 318-675-7065; Email: stephanie.saunders@lsuhs.edu

Study Locations

• United States
  • Louisiana
    • Shreveport, Louisiana, United States, 71101
      • Recruiting
      • LSU Health Shreveport
      • Contact: Shawn McNeil, MD; Phone Number: 318-675-7065; Email: shawn.mcneil@lsuhs.edu
      • Contact: Stephanie Saunders, MA, CCRC; Phone Number: 318-675-7065; Email: stephanie.saunders@lsuhs.edu
      • Principal Investigator: Shawn McNeil, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lumateperone; 42mg capsule, once a day for 8 weeks	Drug: Lumateperone 42 mg; Standard treatment with lumateperone; Other Names: Lumateperone
Active Comparator: Existing medication; Existing medication reformulated in capsule, once or twice daily (as currently prescribed) for 8 weeks	Drug: Risperidone 2 mg; Standard treatment with other antipsychotic drugs; Other Names: olanzapine; quetiapine; ziprasidone; aripiprazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Louisiana State University Health Sciences Center Shreveport
• Investigators: Principal Investigator: Shawn McNeil, MD, LSU Health Shreveport

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: June 26, 2024
• First Submitted That Met QC Criteria: June 26, 2024
• First Posted (Actual): July 1, 2024

Study Record Updates

• Last Update Posted (Actual): July 1, 2024
• Last Update Submitted That Met QC Criteria: June 26, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Schizophrenia; Psychosis; Schizoaffective; Psychotic
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders; Mental Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Dopamine Agonists; Dopamine Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Selective Serotonin Reuptake Inhibitors; Olanzapine; Aripiprazole; Quetiapine Fumarate; Risperidone; Ziprasidone
• Other Study ID Numbers: STUDY00002212

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No