Actively Recruiting
Lumateperone for the Improvement of Apathy in Patients With Psychotic Symptoms.
Led by Louisiana State University Health Sciences Center Shreveport · Updated on 2024-07-01
80
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Lumateperone for the Improvement of Apathy in Patients With Psychotic Symptoms.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects between the ages of 18-65 diagnosed with Schizophrenia, Schizoaffective Disorder, or Schizophrenia Spectrum and Other Psychotic Disorders
- A BPRS score greater than 35 at the screening visit
- An AES-C score greater than 32 at the screening visit
- Stable therapeutic regimen for at least 30 days prior to screening, including medication, supplements, or probiotics
- Ability to participate in all scheduled evaluations and likely compliance with assessments
- Female subjects of childbearing potential must not be pregnant or breastfeeding and must have a negative urine pregnancy test
- Subjects of childbearing or child-fathering potential must agree to use medically acceptable birth control or abstinence during the study and for 30 days after last dose
- Ability to speak and understand English
- Willingness to take and pass a urine drug screen to rule out drug-induced psychotic symptoms
You will not qualify if you...
- A BPRS score less than 35 at the screening visit
- An AES-C score less than 32 at the screening visit
- Clinically significant medical condition or unstable illness that would prevent participation
- Currently taking more than one antipsychotic medication
- Currently receiving long-acting injectable medication for psychotic symptoms
- Substance use disorder or positive drug screen for stimulants
- Pregnant or female without pregnancy prevention measures
- Presence of dementia
- Intellectual disability or cognitive impairment affecting symptom or apathy assessments
- Diagnosis of Parkinson's disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
LSU Health Shreveport
Shreveport, Louisiana, United States, 71101
Actively Recruiting
Research Team
S
Shawn McNeil, MD
CONTACT
S
Stephanie Saunders, MA, CCRC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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