Lumateperone for Schizophrenia

No longer recruiting at 47 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests lumateperone, a new treatment, to determine its effectiveness for people with schizophrenia. The trial compares lumateperone to a placebo (a substance with no active medication) to assess its efficacy and safety. Suitable participants have had schizophrenia for at least a year and are currently experiencing a psychotic episode (a period of loss of contact with reality) lasting less than four weeks. Participants must also have a caregiver who can join the trial process. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

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.

Is there any evidence suggesting that Lumateperone is likely to be safe for humans?

Research has shown that lumateperone is generally safe and well-tolerated. Studies found no serious side effects directly linked to the drug. Its safety profile was similar to that of a placebo, a harmless pill used in studies. Over 2,600 adults with schizophrenia and bipolar depression have taken lumateperone without major safety issues. This suggests that lumateperone is quite safe for people with schizophrenia. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike standard treatments for schizophrenia, which often focus on dopamine receptors, lumateperone offers a unique mechanism of action that targets serotonin, dopamine, and glutamate pathways simultaneously. This triple-action approach may lead to improved symptom control with potentially fewer side effects. Researchers are particularly excited about lumateperone because it might offer a more balanced treatment option, providing relief from both positive and negative symptoms of schizophrenia while minimizing the risks commonly associated with current antipsychotic medications.

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

Research shows that lumateperone, which participants in this trial may receive, effectively treats schizophrenia. Studies have found it significantly reduces both positive symptoms (like hallucinations) and negative symptoms (such as limited emotional expression) compared to a placebo. In one study, patients taking lumateperone experienced a clear improvement in symptoms during severe episodes of schizophrenia. Another study found a 63% lower risk of relapse for those using lumateperone. Overall, evidence supports lumateperone as an effective option for managing schizophrenia symptoms. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 (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 (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]

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]

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 (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 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]

Citations

1.

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.

2.

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 ...

3.

jnj.com

jnj.com/media-center/press-releases/supplemental-new-drug-application-submitted-to-u-s-fda-for-caplyta-lumateperone-with-data-demonstrating-significant-schizophrenia-relapse-prevention-compared-to-placebo

Supplemental new drug application submitted to U.S. FDA ...

Submission is based on long-term Phase 3 data demonstrating 63 percent reduction in risk of relapse in adults with schizophrenia compared to placebo.

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.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10741391/

The Novel Antipsychotic Lumateperone (Iti-007) in the ...

Lumateperone has demonstrated effectiveness in addressing positive, negative, and cognitive symptoms associated with schizophrenia.

6.

pmc.ncbi.nlm.nih.gov

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

F46. LUMATEPERONE (ITI-007): FAVORABLE SAFETY ...

Lumateperone was generally well-tolerated with a favorable safety profile. There was no drug related serious adverse event. In comparison to treatment with SOC ...

7.

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 ...

8.

caplytahcp.com

caplytahcp.com/safety-summary

Safety Summary | CAPLYTA® (lumateperone)

Across 3 indications, CAPLYTA was similar to placebo in1,2*: · CAPLYTA demonstrated safety in 2,664 adult patients with bipolar depression and schizophrenia ...