Lumateperone for Schizophrenia

Overseen By Stephanie Saunders, MA, CCRC

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Louisiana State University Health Sciences Center Shreveport

Must not be taking: Multiple antipsychotics, Injectables

Disqualifiers: Substance use disorder, Dementia, Parkinson's, others

No Placebo Group All 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 Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Lumateperone, an antipsychotic medication, to determine if it can boost motivation in individuals with schizophrenia or schizoaffective disorders who experience high levels of apathy. Researchers aim to discover whether improvements in apathy lead to positive changes in other symptoms of these conditions. Participants will take either Lumateperone or an existing medication for eight weeks. This trial may suit individuals diagnosed with schizophrenia or schizoaffective disorders who feel apathetic and have a stable treatment routine. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that lumateperone is generally safe and well-tolerated. In earlier studies, patients taking lumateperone did not experience serious side effects related to the drug. Unlike similar medications, it did not cause weight gain, changes in metabolism, or sexual side effects, which are common concerns. Many patients felt comfortable using the treatment long-term, with about 90% choosing to continue in extended safety studies. Overall, lumateperone has demonstrated a good safety record, making it a promising option for treating symptoms of schizophrenia. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for schizophrenia?

Unlike standard schizophrenia treatments, which often focus on dopamine pathways, Lumateperone offers a unique approach by targeting serotonin and glutamate systems as well. This multi-faceted mechanism might reduce symptoms with fewer side effects, a significant concern with existing therapies like antipsychotics. Researchers are excited because Lumateperone could potentially offer a more balanced and tolerable treatment option for patients, improving both efficacy and quality of life.

What evidence suggests that Lumateperone might be an effective treatment for schizophrenia?

This trial will compare Lumateperone with an existing medication for schizophrenia. Studies have shown that Lumateperone effectively treats schizophrenia by reducing both positive symptoms, such as delusions and hallucinations, and negative symptoms, like lack of motivation and emotion. Research indicates that patients taking Lumateperone have experienced significant improvements in overall symptoms compared to those on a placebo. Specifically, one study showed a 13.2-point reduction in the PANSS (Positive and Negative Syndrome Scale) total score, which measures the severity of schizophrenia symptoms. Additionally, Lumateperone has proven effective in delaying relapse, helping prevent symptoms from returning for a longer time. Overall, Lumateperone is a reliable option for managing schizophrenia symptoms. ^{1 6 7 8 9}

Who Is on the Research Team?

Shawn McNeil, MD

Principal Investigator

LSU Health Shreveport

Are You a Good Fit for This Trial?

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

Must speak and understand English

My current treatment plan has been the same for at least 30 days.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Existing medication Active Control 1 Intervention

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

Group II: Lumateperone Active Control 1 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)

Who Is Running the Clinical Trial?

Louisiana State University Health Sciences Center Shreveport

Lead Sponsor

Trials

52

Recruited

19,400+

Published Research Related to This Trial

Lumateperone (CaptylaR) is a new atypical antipsychotic approved by the FDA for treating schizophrenia, offering a potential option for patients with treatment-resistant cases or those at risk for metabolic issues and movement disorders.

However, lumateperone is not recommended for certain populations, including pregnant or breastfeeding women, children, adolescents, elderly patients with dementia-related psychosis, and those with specific health risks, highlighting the need for careful patient selection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of lumateperone in the treatment of schizophrenia. Syed, AB., Brašić, JR.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 42 mg has a favorable safety and tolerability profile in treating schizophrenia, with treatment-emergent adverse events (TEAEs) being predominantly mild and similar to placebo (0.5% discontinuation rate) compared to risperidone (4.7%).

The treatment did not significantly affect metabolic parameters or cause weight gain, showing less impact on these factors than risperidone, making lumateperone a potentially better-tolerated option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of lumateperone for the treatment of schizophrenia: a pooled analysis of late-phase placebo- and active-controlled clinical trials. Kane, JM., Durgam, S., Satlin, A., et al.[2023]

Lumateperone, approved by the FDA for schizophrenia and bipolar depression, works by partially activating dopamine D2 receptors and also affects the dopamine transporter, NMDA receptor, and serotonin transporter, which contributes to its therapeutic effects.

Clinical trials indicate that lumateperone has a favorable metabolic profile, showing less weight gain and better body measurements compared to other second-generation antipsychotics, while demonstrating efficacy and safety in treating schizophrenia and bipolar disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Illuminating Hope for Mental Health: A Drug Review on Lumateperone. Tarzian, M., Ndrio, M., Chique, B., et al.[2023]

Lumateperone (LUM) has been shown to significantly reduce the severity of schizophrenia symptoms compared to placebo, based on data from four clinical studies involving randomized controlled trials and an open-label trial.

LUM has a favorable safety and tolerability profile, exhibiting placebo-level rates of weight gain, metabolic changes, and extrapyramidal side effects, making it a strong candidate for first-line treatment in adults with schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lumateperone for the Treatment of Adults With Schizophrenia: a Systematic Review. Jawad, MY., Alnefeesi, Y., Ceban, F., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lumateperone: First Approval. Blair, HA.[2021]

Lumateperone (Caplyta®) is a newly approved medication for schizophrenia that works by blocking serotonin 2A receptors and has a unique mechanism involving partial agonism at presynaptic dopamine receptors and modulation of glutamate receptors, which may help address symptoms of the disorder.

Clinical trials (Phase II and III) suggest that Lumateperone's novel mechanism could offer benefits in treating schizophrenia, although it shares similarities with existing second- and third-generation antipsychotics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lumateperone: New Drug or Same Old Drug With a New Dress? Limandri, BJ.[2021]

Citations

1. jnj.com jnj.com/media-center/press-releases/fda-approval-of-caplyta-lumateperone-has-the-potential-to-reset-treatment-expectations-offering-hope-for-remission-in-adults-with-major-depressive-disorder

FDA approval of CAPLYTA® (lumateperone) has the ... CAPLYTA®, added to an antidepressant, demonstrated robust efficacy for the treatment of MDD in the primary endpoint, the MADRS Total score, with ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7511146/

Lumateperone for the Treatment of Schizophrenia - PMC Lumateperone has been shown to effectively reduce both the positive and negative symptoms of schizophrenia when compared with placebo.

3. caplytahcp.com caplytahcp.com/schizophrenia/primary-efficacy

Primary Efficacy - Schizophrenia | CAPLYTA® (lumateperone) At 4 weeks, patients on risperidone saw a 13.4-point reduction in PANSS total score, patients on CAPLYTA saw a 13.2-point reduction in PANSS total score, and ...

4. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/2758022

Efficacy and Safety of Lumateperone for Treatment ... Treatment with 42 mg of lumateperone compared with placebo significantly improved symptoms in patients with acute exacerbation of schizophrenia ...

5. psychiatrist.com psychiatrist.com/news/caplyta-shows-promise-in-preventing-schizophrenia-relapse/

Caplyta Shows Promise in Preventing Schizophrenia ... In short, patients treated with lumateperone enjoyed a much longer time to relapse compared to those on a placebo, with a 63% reduction in ...

6. caplytahcp.com caplytahcp.com/long-term-data

Long-Term Safety Data | CAPLYTA® (lumateperone) Patients on CAPLYTA sustained treatment over 6 months1,2. 9 out of 10 patients chose to continue into the open-label safety extension, and 85% stayed on ...

7. cureus.com cureus.com/articles/415017-lumateperone-safety-and-tolerability-in-schizophrenia-a-narrative-review

Lumateperone Safety and Tolerability in Schizophrenia Current findings suggest that lumateperone reduces core symptoms of schizophrenia while demonstrating a more favorable safety profile than many ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5888466/

F46. LUMATEPERONE (ITI-007): FAVORABLE SAFETY ... Results. Lumateperone was generally well-tolerated with a favorable safety profile. There was no drug related serious adverse event. In comparison to treatment ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT06229210

Study Details | NCT06229210 | Safety and Tolerability Trial ... This is a multicenter, global, 26-week, open-label study to assess the safety and tolerability of lumateperone in pediatric patients with schizophrenia, bipolar ...