Luteolin for Schizophrenia

Recruiting at 1 trial location

Overseen By Jennifer Zaranski

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Must be taking: Antipsychotics

Must not be taking: Immunosuppressives, Anti-inflammatories

Disqualifiers: Substance misuse, Infection, Pregnancy, others

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests if luteolin, a natural substance found in some foods, can help people with schizophrenia who still have symptoms and cognitive issues. Luteolin might improve brain function by reducing inflammation and protecting brain cells.

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

You must stay on the same antipsychotic medication you've been taking for at least 60 days. However, you cannot take immunosuppressive or certain anti-inflammatory medications regularly. PRN anti-inflammatory agents are allowed.

Will I have to stop taking my current medications?

The trial requires that you have been on the same antipsychotic medication for at least 60 days and at a constant dose for at least 30 days before joining. However, you cannot take certain medications like immunosuppressive drugs or daily anti-inflammatory medications.

What data supports the idea that Luteolin for Schizophrenia is an effective treatment?

The available research does not provide any data supporting the effectiveness of Luteolin for treating schizophrenia. Instead, the research focuses on another drug called Lumateperone, which has shown promise in treating schizophrenia by improving symptoms like social function and depression with fewer side effects. Lumateperone works by affecting key brain chemicals and has been tested in clinical trials, showing positive results for people with schizophrenia. ^{1 2 3 4 5}

What safety data is available for Luteolin in treating schizophrenia?

The provided research does not contain any safety data for Luteolin or its other names (Luteolol, Digitoflavone, Flacitran, Luteoline) in the treatment of schizophrenia. The studies focus on other antipsychotic treatments such as lumateperone, sertindole, and second-generation antipsychotic long-acting injections. ^{2 6 7 8 9}

Is the drug Luteolin a promising treatment for schizophrenia?

The provided research articles focus on Lumateperone, not Luteolin, as a promising drug for schizophrenia. Therefore, there is no information here to suggest that Luteolin is a promising treatment for schizophrenia. ^{1 2 3 4 10}

Research Team

Robert W Buchanan, M.D.

Principal Investigator

University of Maryland, Baltimore

Eligibility Criteria

This trial is for adults aged 18-60 with schizophrenia or schizoaffective disorder, who have been on a stable dose of antipsychotics for at least two months. Participants must be clinically stable and not using substances (except mild marijuana use), immunosuppressives, high-dose anti-inflammatories, or have infections that could affect the study.

Inclusion Criteria

My mental health condition is severe, as shown by my test scores.

I've been on the same antipsychotic medication for 60 days, with a stable dose for the last 30 days.

I can understand and agree to the study's consent form.

Exclusion Criteria

I am not pregnant or nursing.

I do not have an infection like HIV or Hepatitis C, or a brain disorder that could affect my schizophrenia treatment.

Meets DSM-5 criteria for alcohol or substance misuse (except caffeine and nicotine) within the last 6 months; or a positive baseline urine drug screen. Participants who meet DSM-5 criteria for marijuana misuse - mild will be included in the study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either 300mg BID luteolin or placebo for 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Luteolin

Trial Overview The study tests if Luteolin, a natural compound in foods like celery and parsley known for its health benefits, can improve symptoms of schizophrenia when compared to a placebo (a substance with no active drug).

Participant Groups

Group I: Luteolin Active Control 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

University of California, Los Angeles

Collaborator

Trials

1,594

Recruited

10,430,000+

Stanley Medical Research Institute

Collaborator

Trials

141

Recruited

10,400+

Findings from Research

Lumateperone (CAPLYTA™) is a novel antipsychotic approved for treating schizophrenia, showing efficacy in managing a broad range of symptoms, including positive symptoms and comorbid depression, based on data from 20 clinical trials involving over 1900 participants.

This medication works by simultaneously modulating serotonin, dopamine, and glutamate neurotransmission, which contributes to its effectiveness while maintaining a favorable safety profile with fewer intolerable side effects compared to traditional antipsychotics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of the pharmacology and clinical profile of lumateperone for the treatment of schizophrenia. Snyder, GL., Vanover, KE., Davis, RE., et al.[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 (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]

In a phase 3 clinical trial involving 450 patients, lumateperone (42 mg) significantly improved schizophrenia symptoms compared to placebo, as measured by the Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impression-Severity (CGI-S) scores.

Lumateperone was well tolerated, showing no significant motor side effects or adverse changes in cardiometabolic or endocrine factors, suggesting it may be a safer alternative to current antipsychotic medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Lumateperone for Treatment of Schizophrenia: A Randomized Clinical Trial. Correll, CU., Davis, RE., Weingart, M., et al.[2021]

In a review of 157 patients with schizophrenia, 6.9% of those on aripiprazole, 12.2% on paliperidone palmitate, and 17.2% on risperidone-LAI discontinued treatment due to adverse events, indicating that while some patients experience side effects, the majority tolerate the medication well.

Most adverse events were of moderate severity, with only three patients requiring hospitalization, suggesting that while LAI-SGA therapy can lead to discontinuation in some cases, serious complications are relatively rare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of patients with schizophrenia who discontinued long-acting injectable antipsychotic therapy due to adverse events: A chart review. Kishi, T., Sakuma, K., Okuya, M., et al.[2022]

Second-generation antipsychotic long-acting injections (SGA-LAIs) like aripiprazole and olanzapine are associated with significant treatment-emergent adverse events (TEAEs), including psychotic symptoms, extrapyramidal symptoms, weight gain, and metabolic disturbances, indicating safety concerns in their use.

The review highlights that SGA-LAIs do not demonstrate safety advantages over first-generation antipsychotics or oral medications, suggesting that non-pharmacological interventions may be beneficial for patients with schizophrenia and bipolar disorder who struggle with medication adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety concerns associated with second-generation antipsychotic long-acting injection treatment. A systematic update. Gentile, S.[2019]

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]

In a long-term study involving 294 patients with schizophrenia, sertindole demonstrated safety and tolerability, with significant clinical improvement as measured by reductions in the Positive And Negative Syndrome Scale and Clinical Global Impression scores.

While 13% of patients withdrew due to adverse events, the most common side effects were fatigue and weight gain (14% each), and the incidence of extrapyramidal symptoms was 18%, indicating that while sertindole is effective, monitoring for side effects is important.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sertindole in the long-term treatment of schizophrenia. Hale, AS., Azorin, JM., Lemming, OM., et al.[2014]

Lumateperone (ITI-007) has a unique mechanism of action that targets multiple neurotransmitter systems, including serotonin, dopamine, and glutamate, making it a promising treatment for schizophrenia and potentially other psychiatric conditions.

It has shown a favorable safety profile, with no significant side effects like extrapyramidal symptoms or hyperprolactinemia, suggesting it could be a safer alternative to traditional antipsychotics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence on the New Drug Lumateperone (ITI-007) for Psychiatric and Neurological Disorders. Mazza, M., Marano, G., Traversi, G., et al.[2021]

References

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

A review of the pharmacology and clinical profile of lumateperone for the treatment of schizophrenia. [2021]

2. England pubmed.ncbi.nlm.nih.gov

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

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

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

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

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

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

Efficacy and Safety of Lumateperone for Treatment of Schizophrenia: A Randomized Clinical Trial. [2021]

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

Outcomes of patients with schizophrenia who discontinued long-acting injectable antipsychotic therapy due to adverse events: A chart review. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Safety concerns associated with second-generation antipsychotic long-acting injection treatment. A systematic update. [2019]

8. 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]

9. England pubmed.ncbi.nlm.nih.gov

Sertindole in the long-term treatment of schizophrenia. [2014]

10. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Evidence on the New Drug Lumateperone (ITI-007) for Psychiatric and Neurological Disorders. [2021]