ApathyPhase 3NCT06482554
Lumateperone for the Improvement of Apathy in Patients With Psychotic Symptoms.
A Phase 3 study testing Lumateperone 42 mg and Risperidone 2 mg in people with Apathy and Schizophrenia, run by Louisiana State University Health Sciences Center Shreveport at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Apathy, Schizophrenia, Schizophrenia; Psychosis
- What is being tested?
- Lumateperone 42 mg and Risperidone 2 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2024to Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
LSU Health Shreveport
Shreveport, Louisiana, 71101
Stephanie Saunders, MA, CCRC, 318-675-7065, stephanie.saunders@lsuhs.edu
Shawn McNeil, MD, 318-675-7065, shawn.mcneil@lsuhs.edu
About this study
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.
Read the detailed description
- 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 assessment.
- 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
- Apathy, Schizophrenia, Schizophrenia; Psychosis
- Being tested
- Lumateperone 42 mg, Risperidone 2 mg
- Keywords
- Schizophrenia, Schizoaffective, Psychosis, Psychotic
- Medical subject headings
- Lethargy, Schizophrenia, Psychotic Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumateperone 42 mgDrug
Also called Lumateperone
Standard treatment with lumateperone
Risperidone 2 mgDrug
Also called olanzapine; quetiapine; ziprasidone; aripiprazole
Standard treatment with other antipsychotic drugs
| Study group | Role | What they receive |
|---|---|---|
| Lumateperone | Active comparator | 42mg capsule, once a day for 8 weeks Receives: Drug: Lumateperone 42 mg |
| Existing medication | Active comparator | Existing medication reformulated in capsule, once or twice daily (as currently prescribed) for 8 weeks Receives: Drug: Risperidone 2 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in AES-C Score
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.
Measured: 8 weeks
Secondary outcomes (3)
Change in PANSS Score
Difference between the mean change in the PANSS score from baseline (V1) to Week 8 (V3) for 42 mg/day lumateperone vs. current antipsychotic medication.
Measured: 8 weeks
Change in BPRS Score
Difference between the mean change in the BPRS (Brief Psychiatric Rating Scale) score from baseline (V1) to Week 8 (V3) for 42 mg/day lumateperone vs. current antipsychotic medication.
Measured: 8 weeks
Correlations between AES-C and PANSS Scores
Correlation between the AES-C score at Week 8 (V3) and negative symptoms score from PANSS at Week 8 (V3) for 42 mg/day lumateperone in comparison to current antipsychotic medication.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study startJun 2024 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ApathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Compare lumateperone treatment with existing medication
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center Shreveport
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shawn McNeil, Louisiana State University Health Sciences Center Shreveport
- Investigators
- Shawn McNeil, MD, Principal investigator, LSU Health Shreveport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06482554
- Sponsor's protocol ID
- STUDY00002212
- Status last verified
- Jun 2024
- First submitted
- 26 Jun 2024
- Last updated
- 1 Jul 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lumateperone for the Improvement of Apathy in Patients With Psychotic Symptoms.
- ClinicalTrials.gov ID
- NCT06482554
- Acronym / sponsor ID
- STUDY00002212
- Conditions
- Apathy, Schizophrenia, Schizophrenia; Psychosis
- Keywords
- Schizophrenia, Schizoaffective, Psychosis, Psychotic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Louisiana State University Health Sciences Center ShreveportUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 1 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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 assessment.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Compare lumateperone treatment with existing medication
| Arm | Type | Receives |
|---|---|---|
| Lumateperone | Active comparator | Drug: Lumateperone 42 mg42mg capsule, once a day for 8 weeks |
| Existing medication | Active comparator | Drug: Risperidone 2 mgExisting medication reformulated in capsule, once or twice daily (as currently prescribed) for 8 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumateperone 42 mgAlso: LumateperoneStandard treatment with lumateperone | Drug | Lumateperone |
| Risperidone 2 mgAlso: olanzapine; quetiapine; ziprasidone; aripiprazoleStandard treatment with other antipsychotic drugs | Drug | Existing medication |
Primary outcome
Change in AES-C Score
Time frame: 8 weeks
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.
3 secondary outcomes
Change in PANSS Score
Time frame: 8 weeks
Change in BPRS Score
Time frame: 8 weeks
Correlations between AES-C and PANSS Scores
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shawn McNeil, MD principal investigator
LSU Health Shreveport
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lumateperone 42 mg and Risperidone 2 mg in people with Apathy and Schizophrenia, run by Louisiana State University Health Sciences Center Shreveport at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shawn McNeil, MD (318-675-7065, shawn.mcneil@lsuhs.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in AES-C Score (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2024.