Lumateperone for the Improvement of Apathy in Patients With Psychotic Symptoms.
Recruiting
Phase 3
Interventional Study
Apathy
Schizophrenia
Schizophrenia; Psychosis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 65
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 80 (estimated)
- Sponsor
- Louisiana State University Health Sciences Center Shreveport · Other
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About This Trial
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…
Trial Locations
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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…
Contacts