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RecruitingNCT06482554Updated Jul 1, 2024

Lumateperone for the Improvement of Apathy in Patients With Psychotic Symptoms.

A Phase 3 interventional study of Lumateperone 42 mg and Risperidone 2 mg in Apathy, Schizophrenia and Schizophrenia; Psychosis, sponsored by Louisiana State University Health Sciences Center Shreveport. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-07-01.

Sponsored by Louisiana State University Health Sciences Center Shreveport · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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 scores and changes in elements of the PANSS (Positive and Negative Syndrome Scale) due to treatment with Lumateperone.

Read the detailed description
  1. 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.
  2. 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.
02

Conditions studied

  • Apathy
  • Schizophrenia
  • Schizophrenia; Psychosis

Keywords

  • Schizophrenia
  • Schizoaffective
  • Psychosis
  • Psychotic
03

In context

Schizophrenia

3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.

This study's planned enrollment of 80 is above the median of 71 across 2,944 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Louisiana State University Health Sciences Center Shreveport is the lead sponsor of 44 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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 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 , 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.

Exclusion criteria

Exclusion Criteria:

  • A BPRS score \< 35 at the screening visit.
  • An AES-C score \< 32 at the screening visit.
  • Have any 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
80 participants (estimated)

Study arms

  • Active comparator
    Lumateperone

    42mg capsule, once a day for 8 weeks

    Drug: Lumateperone 42 mg

  • Active comparator
    Existing medication

    Existing medication reformulated in capsule, once or twice daily (as currently prescribed) for 8 weeks

    Drug: Risperidone 2 mg

Interventions

  • DrugLumateperone 42 mg

    Standard treatment with lumateperone

    Also known as: Lumateperone

  • DrugRisperidone 2 mg

    Standard treatment with other antipsychotic drugs

    Also known as: olanzapine; quetiapine; ziprasidone; aripiprazole

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 8 weeks

Secondary outcomes

  1. 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.

    Time frame: 8 weeks

  2. 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.

    Time frame: 8 weeks

  3. 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.

    Time frame: 8 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2024; primary completion for Dec 2026, 30 months later.

Of 113 phase 3 interventional studies under Schizophrenia, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 46. This study's planned 30 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 26, 2024
First posted
Jul 1, 2024
StartEst.
Jun 2024
Primary completionEst.
Dec 2026
CompletionEst.
Dec 2026
Last update
Jul 1, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06482554
Lead sponsor
Louisiana State University Health Sciences Center Shreveport
Responsible party
Shawn McNeil (Principal Investigator, Louisiana State University Health Sciences Center Shreveport) — Principal investigator
First posted
Jul 1, 2024
Start date
Jun 2024 (estimated)
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Jul 1, 2024

Study contacts

Shawn McNeil, MD
Contact
shawn.mcneil@lsuhs.edu
318-675-7065
Stephanie Saunders, MA, CCRC
Contact
stephanie.saunders@lsuhs.edu
318-675-7065
Shawn McNeil, MD
principal investigator · LSU Health Shreveport

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Lumateperone · Risperidone

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