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New treatment option for Apathy
Official title Lumateperone for the Improvement of Apathy in Patients With Psychotic Symptoms.
ClinicalTrials.gov ID: NCT06482554
What this study is testing
What is Lumateperone 42 mg?
Lumateperone 42 mg is an investigational medicine, being studied as a potential treatment for apathy.
Also referred to as Lumateperone.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Male or female people between the ages of 18-65 that have been diagnosed with Schizophrenia, Schizoaffective Disorder or Schizophrenia Spectrum and...
- 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...
- In the opinion of the Investigator, the subject is able to participate in all scheduled evaluations, and likely to be compliant and complete all...
You likely can't join 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...
- 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.
See the full eligibility criteria
- Male or female people 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 people of childbearing potential must not be pregnant or breast-feeding. Female people of childbearing potential must have a negative urine pregnancy test. people of childbearing or child-fathering potential must...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shreveport, Louisiana, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shreveport, Louisiana, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.