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NCT06482554 · ClinicalTrials.gov registry record · Phase 3
Lumateperone for the Improvement of Apathy in Patients With Psychotic Symptoms.
A Phase 3 study of Schizophrenia and Apathy, sponsored by Louisiana State University Health Sciences Center Shreveport.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT06482554: Recruiting Phase 3 study of Schizophrenia and Apathy, sponsored by Louisiana State University Health Sciences Center Shreveport.
NCT06482554 is a Phase 3 study of Schizophrenia and Apathy that is actively recruiting participants, run by Louisiana State University Health Sciences Center Shreveport. The registered enrollment target is 80 participants, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (63% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06482554, a Phase 3 study of Schizophrenia and Apathy, is actively recruiting participants, sponsored by Louisiana State University Health Sciences Center Shreveport.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Lumateperone 42 mg
- DRUG Risperidone 2 mg
Study Locations (1)
Louisiana
- LSU Health Shreveport - Shreveport
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2024-06 |
| Est. Completion | 2026-12 |
| Phase | Phase 3 |
What NCT06482554 shows while recruiting
NCT06482554 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (63% lower).
The record links to 3 conditions, with Schizophrenia appearing as the primary indexed condition, and to 2 interventions - of which Lumateperone 42 mg is the first listed.
NCT06482554 reports a single indexed study location in Louisiana.
Frequently Asked Questions
What is clinical trial NCT06482554 about?
NCT06482554 is a clinical study titled "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 improvem...
What is the current status of trial NCT06482554?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 80 participants. The study started on 2024-06. Estimated completion is 2026-12.
What conditions does trial NCT06482554 study?
This clinical trial studies the following conditions: Schizophrenia, Apathy, Schizophrenia; Psychosis.
What interventions are being tested in trial NCT06482554?
The interventions under investigation include: Lumateperone 42 mg (DRUG), Risperidone 2 mg (DRUG).
Who is sponsoring clinical trial NCT06482554?
This trial is sponsored by Louisiana State University Health Sciences Center Shreveport, which has 40 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06482554 being conducted?
This trial has 1 study location across Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Schizophrenia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06482554's enrollment target sits among peer trials
80 161st of 315 higher than 151 of 315 other Schizophrenia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Schizophrenia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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