What side effects are associated with this type of intervention?

Common treatments for schizophrenia primarily include antipsychotic medications. First-generation antipsychotics, such as haloperidol and chlorpromazine, are associated with extrapyramidal side effects (EPS) like akathisia, dystonia, and parkinsonism. Second-generation antipsychotics, such as risperidone, olanzapine, and quetiapine, tend to cause fewer EPS but can lead to metabolic side effects like weight gain, diabetes, and dyslipidemia. Both classes of antipsychotics can increase the risk of mortality in elderly patients with dementia. Luteolin, being studied for its anti-inflammatory and anti-oxidant properties, does not have the same side effect profile as traditional antipsychotics, but its efficacy and safety in treating schizophrenia are still under investigation.

What prior FDA approvals exist?

The FDA has approved several antipsychotic medications for the treatment of schizophrenia, including both first-generation (e.g., haloperidol, chlorpromazine) and second-generation antipsychotics (e.g., clozapine, risperidone, olanzapine). While these drugs primarily target dopamine receptors to alleviate symptoms, some second-generation antipsychotics like clozapine also exhibit anti-inflammatory properties. However, there is limited information on FDA-approved treatments specifically focusing on anti-inflammatory and anti-oxidant properties similar to luteolin. Research is ongoing to explore the potential benefits of such treatments in managing schizophrenia.

What other types of research exist?

Promising novel alternatives to Luteolin for schizophrenia patients include: 1) Cannabidiol (CBD), which has shown anti-inflammatory and antioxidant properties and potential benefits in reducing psychotic symptoms. 2) N-acetylcysteine (NAC), an antioxidant that has been studied for its potential to improve symptoms in schizophrenia. 3) Omega-3 fatty acids, which have anti-inflammatory effects and have been investigated for their role in managing schizophrenia symptoms.

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Flavonoid

Luteolin for Schizophrenia

N/A

Recruiting

Led By Robert W Buchanan, M.D.

Research Sponsored by University of Maryland, Baltimore

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Positive and Negative Syndrome Scale (PANSS) total score of 75 or more OR a Clinical Global Impression severity of illness item score of 4 or more

Treated with the same antipsychotic for at least 60 days and have received a constant therapeutic dose for at least 30 days prior to study entry

Must not have

Female participants who are pregnant or nursing

A current infection, including HIV and Hepatitis C; or an organic brain disorder or medical condition, whose pathology or treatment could alter the presentation or treatment of schizophrenia or significantly increase the risk associated with the proposed treatment protocol

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Summary

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.

Who is the study for?

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.

What is being tested?

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).

What are the potential side effects?

While specific side effects are not listed here, Luteolin may cause reactions related to its anti-inflammatory properties. As it's being tested against a placebo which has no treatment effect, any side effects would likely stem from Luteolin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I have been diagnosed with schizophrenia or schizoaffective disorder.

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I am between 18 and 60 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant or nursing.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cognition and oxidative stress

Cognitive impairments

Global oxidative stress

+1 more

Secondary study objectives

Negative symptoms of schizophrenia

Positive symptoms of schizophrenia

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: LuteolinActive Control1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for schizophrenia primarily involve antipsychotic medications, which work by modulating neurotransmitter activity in the brain, particularly dopamine and serotonin pathways. These medications help reduce symptoms such as hallucinations, delusions, and thought disorders. Additionally, emerging treatments like Luteolin, which possess anti-inflammatory and anti-oxidant properties, are being studied for their potential to address the neuroinflammatory and oxidative stress components of schizophrenia. This is significant for patients as it may offer a broader therapeutic approach, potentially improving symptoms and overall brain health beyond the capabilities of traditional antipsychotics.

Treatment of early onset schizophrenia: recent trends, challenges and future considerations.Minocycline benefits negative symptoms in early schizophrenia: a randomised double-blind placebo-controlled clinical trial in patients on standard treatment.Efficacy of anti-inflammatory agents to improve symptoms in patients with schizophrenia: an update.