Lumateperone for Schizophrenia

Recruiting at 44 trial locations

Overseen By ITI Clinical Trials

Age: 18 - 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Intra-Cellular Therapies, Inc.

Must be taking: Antipsychotics

Disqualifiers: Bipolar, Substance use, Personality, others

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: Unknown

228 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests lumateperone, a medication for adults with schizophrenia. It aims to see if the drug can balance brain chemicals to improve symptoms like hallucinations and disorganized thinking. Lumateperone is approved for treating schizophrenia and depressive episodes related to bipolar depression in adults.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Lumateperone has been shown to be effective in treating schizophrenia symptoms in clinical trials, with its unique action on brain chemicals like serotonin, dopamine, and glutamate. It is approved by the FDA for schizophrenia and is being studied for other mental health conditions. ^{1 2 3 4 5}

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 sleepiness and dry mouth. In studies, it had a similar safety profile to a placebo and was better tolerated than some other antipsychotic medications. ^{1 2 3 4 6}

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. ^{1 3 4 7 8}

Eligibility Criteria

Adults aged 18-60 with schizophrenia for at least a year, experiencing moderate symptoms like delusions or hallucinations. They must have a caregiver and be at risk of suicide. Excluded are those with other mental disorders, recent substance abuse, treatment-resistant schizophrenia, or in their first psychosis episode.

Inclusion Criteria

I have been diagnosed with schizophrenia for at least a year.

PANSS total score ≥ 70 and ≤ 120 at Visit 1 and Visit 2

I have been diagnosed with schizophrenia based on DSM-5 criteria.

Exclusion Criteria

Patients in their first episode of psychosis

Currently meeting DSM-5 criteria for any of the following: Schizoaffective disorder, schizophreniform disorder, and other psychotic disorders; Bipolar I or Bipolar II Disorder; Intellectual developmental disorder, delirium, dementia, amnestic and other cognitive disorders; Known or suspected borderline or antisocial personality disorder or other DSM 5 personality disorder of sufficient severity to interfere with participation in this study; Substance use disorder (other than nicotine) within the 3 months prior to Visit 1 of this study

My schizophrenia hasn't improved after trying at least 2 different medications for over 6 weeks each.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

up to 1 week

Run-in

All patients receive oral lumateperone 42 mg/day

6 weeks

Stabilization

All patients continue to receive oral lumateperone 42 mg/day

12 weeks

Double-blind Treatment

Patients receive either lumateperone 42 mg or placebo in a 1:1 ratio

26 weeks

Safety Follow-up

Participants are monitored for safety after treatment

2 weeks

Treatment Details

Interventions

• Lumateperone

Trial Overview The study is testing Lumateperone (42 mg) against a placebo to prevent relapse in schizophrenia patients. It's conducted across multiple centers where participants are randomly assigned to either the drug or placebo group without knowing which one they receive.

Participant Groups

Group I: Lumateperone 42 mg Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

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?

Intra-Cellular Therapies, Inc.

Lead Sponsor

Trials

42

Recruited

10,700+

Findings from Research

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]

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 (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 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 (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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Lumateperone: New Drug or Same Old Drug With a New Dress? [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Safety and tolerability of lumateperone 42 mg: An open-label antipsychotic switch study in outpatients with stable schizophrenia. [2021]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Lumateperone: First Approval. [2021]

4. England pubmed.ncbi.nlm.nih.gov

An evaluation of lumateperone tosylate for the treatment of schizophrenia. [2020]

5. England pubmed.ncbi.nlm.nih.gov

The role of lumateperone in the treatment of schizophrenia. [2021]

6. England 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. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Illuminating Hope for Mental Health: A Drug Review on Lumateperone. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Lumateperone for the Treatment of Adults With Schizophrenia: a Systematic Review. [2022]