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

NCT06482554 | Recruiting Phase 3 FDA Drug

• 1 other identifier: STUDY00002212
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

Schizophrenia; Schizoaffective; Psychosis; Psychotic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in PANSS Score

  8 weeks

• Change in BPRS Score

  8 weeks

• Correlations between AES-C and PANSS Scores

  8 weeks

Study Arms (2)

Lumateperone

ACTIVE COMPARATOR

42mg capsule, once a day for 8 weeks

Drug: Lumateperone 42 mg

Existing medication

ACTIVE COMPARATOR

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

Drug: Risperidone 2 mg

Interventions

Lumateperone 42 mg DRUG

Standard treatment with lumateperone

Also known as: Lumateperone

Lumateperone

Risperidone 2 mg DRUG

Standard treatment with other antipsychotic drugs

Also known as: olanzapine; quetiapine; ziprasidone; aripiprazole

Existing medication

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Louisiana State University Health Sciences Center Shreveport: lead

Study Sites (1)

LSU Health Shreveport

Shreveport, Louisiana, 71101, United States

RECRUITING

MeSH Terms

Conditions

Lethargy; Schizophrenia; Psychotic Disorders; Mental Disorders

Interventions

lumateperone; Risperidone; Olanzapine; Quetiapine Fumarate; ziprasidone; Aripiprazole

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Schizophrenia Spectrum and Other Psychotic Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Piperazines; Quinolones; Quinolines

Study Officials

• Shawn McNeil, MD

  LSU Health Shreveport

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shawn McNeil, MD

CONTACT

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

Stephanie Saunders, MA, CCRC

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Compare lumateperone treatment with existing medication

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 1, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)