Luteolin for Schizophrenia

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether luteolin, a natural compound in foods like celery and chamomile tea, can improve symptoms of schizophrenia. Schizophrenia, a mental health condition, can cause delusions and hallucinations, making daily life challenging. Participants will receive either luteolin or a placebo to compare effects. The trial suits individuals with schizophrenia who have been on the same antipsychotic medication for at least 60 days and are clinically stable. As an unphased trial, it offers a unique opportunity to explore potential new benefits of luteolin for managing schizophrenia symptoms.

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.

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

Research shows that luteolin, a natural substance in foods like celery and chamomile tea, offers several health benefits. It may fight cancer and reduce inflammation, but its safety for humans remains unclear.

Some studies have explored luteolin for other health issues. For example, it might protect the brain in conditions like Alzheimer's disease. However, little information exists on its safety for schizophrenia. One study suggested that more research is needed to determine its safety for people.

The trial is in an early stage, so researchers are still learning about how people react to the treatment and what side effects might occur. Since luteolin is in common foods, it is generally safe to eat in normal amounts. However, its safety at the higher doses used in medical trials is still under study.

In summary, while luteolin appears promising, more research is needed to determine its safety for treating schizophrenia. Participants in trials like this help gather important data to assess its safety and effectiveness. ^{1 2 3 4 5}

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

Unlike the standard antipsychotic medications used for schizophrenia, which often focus on altering neurotransmitter levels, Luteolin is unique because it is derived from a naturally occurring flavonoid found in fruits and vegetables. Researchers are excited about Luteolin because it has antioxidant and anti-inflammatory properties that might offer a different approach to managing schizophrenia symptoms. This unique mechanism could potentially lead to fewer side effects compared to traditional medications, making it a promising option for those who struggle with the current treatments.

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

Research suggests that luteolin, a natural substance found in foods like celery and parsley, might help with symptoms of schizophrenia. Although direct proof that it can treat schizophrenia is lacking, luteolin is known to reduce inflammation and protect cells from damage. These effects might help lower stress and inflammation in the brain, which researchers believe are linked to schizophrenia. Some studies have shown that luteolin may also support brain health in other conditions. While more research is needed, these findings suggest luteolin could be useful in managing schizophrenia symptoms. Participants in this trial will receive either luteolin or a placebo to evaluate its effectiveness in treating schizophrenia. ^{1 2 5 6 7}

Who Is on the Research Team?

Robert W Buchanan, M.D.

Principal Investigator

University of Maryland, Baltimore

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 (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]

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]

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 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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05204407

Luteolin for the Treatment of People With Schizophrenia We also hypothesize that luteolin will be associated with improvements in positive and negative symptoms of schizophrenia.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11294387/

Luteolin for neurodegenerative diseases: a review - PMC Luteolin can exhibit beneficial effects in neurodegenerative disorders through various mechanisms including suppression of inflammatory processes, oxidative ...

3. trialx.com trialx.com/clinical-trials/listings/235951/luteolin-for-the-treatment-of-people-with-schizophrenia/?&radius=50

Luteolin for the Treatment of People With Schizophrenia We hypothesize that luteolin will have significant beneficial effects on global psychopathology and cognitive impairments; decrease antioxidant stress and ...

4. umaryland.trialstoday.org umaryland.trialstoday.org/trial/NCT05204407

Luteolin for the Treatment of People With Schizophrenia We also hypothesize that luteolin will be associated with improvements in positive and negative symptoms of schizophrenia.

5. withpower.com withpower.com/trial/phase-schizoaffective-disorders-3-2022-a5474

Luteolin for Schizophrenia The available research does not provide any data supporting the effectiveness of Luteolin for treating schizophrenia. Instead, the research focuses on ...

6. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/330456

Luteolin for the Treatment of People With Schizophrenia Luteolin is a natural product found in foods such as celery, green pepper, parsley, and chamomile tea. It has been found to have anti-cancer ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2095177924001941

Luteolin and its antidepressant properties However, whether it is safe for use in humans remains unclear and requires further evaluation in clinical trials. 8. Perspective and limitations of luteolin as ...