80 Participants Needed

Lumateperone for Schizophrenia

SM
SS
Overseen ByStephanie Saunders, MA, CCRC
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Louisiana State University Health Sciences Center Shreveport
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial requires that your current medication regimen be stable for at least 30 days before joining. If you're taking more than one antipsychotic or a long-acting injectable for psychotic symptoms, you may need to adjust your medications.

What data supports the effectiveness of the drug Lumateperone for treating schizophrenia?

Lumateperone has been shown to be effective in treating schizophrenia through its unique action on brain chemicals like serotonin, dopamine, and glutamate, which help manage symptoms. Clinical trials have demonstrated its efficacy and good tolerability in patients with schizophrenia.12345

Is lumateperone safe for humans?

Lumateperone, also known as Caplyta, has been shown to be generally safe in humans, with most side effects being mild, such as drowsiness and dry mouth. Studies found that it has a favorable safety profile compared to other antipsychotics, with fewer issues like weight gain and movement problems.12356

What makes the drug Lumateperone unique for treating schizophrenia?

Lumateperone is unique because it is a first-in-class drug that simultaneously affects serotonin, dopamine, and glutamate pathways, which may help with a wide range of schizophrenia symptoms. It also has a favorable side effect profile, particularly regarding weight gain, compared to other antipsychotic medications.23578

What is the purpose of this trial?

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.

Research Team

SM

Shawn McNeil, MD

Principal Investigator

LSU Health Shreveport

Eligibility Criteria

This trial is for individuals with schizophrenia or schizoaffective disorders who are notably apathetic. Participants must show high levels of apathy as measured by a specific assessment (AES-C-Apathy). The study excludes details on specific inclusion and exclusion criteria, but these typically involve age, health status, and other medications being taken.

Inclusion Criteria

AES-C score > 32 at the screening visit
My current treatment plan has been the same for at least 30 days.
Must speak and understand English
See 4 more

Exclusion Criteria

I have been diagnosed with Parkinson's disease.
Substance use disorder or positive drug screen for stimulants
I am not pregnant and am using birth control.
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Lumateperone or existing medication for 8 weeks to assess improvement in apathy and correlation with PANSS scores

8 weeks
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Lumateperone
Trial Overview The study tests if Lumateperone (42 mg) can improve motivation compared to Risperidone (2 mg) in patients with schizophrenia-related apathy. It also looks at how changes in motivation might relate to changes in the PANSS scores, which measure different symptoms of schizophrenia.
Participant Groups
2Treatment groups
Active Control
Group I: Existing medicationActive Control1 Intervention
Existing medication reformulated in capsule, once or twice daily (as currently prescribed) for 8 weeks
Group II: LumateperoneActive Control1 Intervention
42mg capsule, once a day for 8 weeks

Lumateperone is already approved in United States for the following indications:

🇺🇸
Approved in United States as Caplyta for:
  • Schizophrenia
  • Bipolar I or II disorder (bipolar depression)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Louisiana State University Health Sciences Center Shreveport

Lead Sponsor

Trials
52
Recruited
19,400+

Findings from Research

In a study of 301 outpatients with stable schizophrenia, lumateperone was found to be well tolerated, with only 45.5% experiencing treatment-emergent adverse events, most of which were mild or moderate, and a very low incidence of extrapyramidal symptoms (1.0%).
Patients switching to lumateperone showed significant improvements in metabolic parameters, such as reduced cholesterol and body weight, while maintaining stable schizophrenia symptoms, indicating its safety and efficacy compared to previous antipsychotic treatments.
Safety and tolerability of lumateperone 42 mg: An open-label antipsychotic switch study in outpatients with stable schizophrenia.Correll, CU., Vanover, KE., Davis, RE., et al.[2021]
Lumateperone is a first-in-class investigational drug for schizophrenia that works by targeting multiple neurotransmitter systems, including serotonergic, glutamatergic, and dopaminergic pathways, which may help alleviate a wide range of symptoms associated with the disorder.
Clinical trials suggest that lumateperone has unique pharmacological properties that could significantly improve schizophrenia symptoms, and future studies are expected to provide more insights into its long-term efficacy and safety.
An evaluation of lumateperone tosylate for the treatment of schizophrenia.Vyas, P., Hwang, BJ., Brašić, JR.[2020]
Lumateperone (Caplyta®) is a first-in-class medication that modulates serotonin, dopamine, and glutamate, making it a unique treatment option for schizophrenia and potentially other neuropsychiatric disorders.
Approved in December 2019 for schizophrenia in adults, lumateperone is also being studied for various conditions, including bipolar depression and Alzheimer's-related behavioral disorders, highlighting its broad therapeutic potential.
Lumateperone: First Approval.Blair, HA.[2021]

References

Safety and tolerability of lumateperone 42 mg: An open-label antipsychotic switch study in outpatients with stable schizophrenia. [2021]
An evaluation of lumateperone tosylate for the treatment of schizophrenia. [2020]
Lumateperone: First Approval. [2021]
The role of lumateperone in the treatment of schizophrenia. [2021]
Lumateperone: New Drug or Same Old Drug With a New Dress? [2021]
Safety and tolerability of lumateperone for the treatment of schizophrenia: a pooled analysis of late-phase placebo- and active-controlled clinical trials. [2023]
Lumateperone for the Treatment of Adults With Schizophrenia: a Systematic Review. [2022]
Illuminating Hope for Mental Health: A Drug Review on Lumateperone. [2023]
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