NCT06482554RecruitingPhase 3
Lumateperone for the Improvement of Apathy in Patients With Psychotic Symptoms.
Source: ClinicalTrials.gov · Last updated 1 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 26 Jun 2024
- Start date
- Jun 2024
- Primary completion date
- Dec 2026
- Lead sponsor
- Louisiana State University Health Sciences Center Shreveport
- Diseases
- Schizophrenia
- NCT number
- NCT06482554
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 80
- From Jun 2024 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Are currently taking more than one antipsychotic medication.
- Are currently taking a long-acting injectable medication for psychotic symptoms.
Other illness
- Have any clinically significant medical condition or an unstable intercurrent illness that would, in the opinion of the Investigator, preclude study participation.
- Have a substance use disorder or show a positive drug screen for stimulants.
- 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.
Other
- A BPRS score \< 35 at the screening visit.
- An AES-C score \< 32 at the screening visit.
- Are pregnant or of female sex with no evidence of measures for pregnancy prevention.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| LSU Health Shreveport Coordinator of this site? Confirm its status | Shreveport | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.