Luteolin for the Treatment of People With Schizophrenia

Study Overview
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Brief Summary
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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, anti-oxidant, and anti-inflammatory properties. The purpose of this study is to determine if luteolin helps improve symptoms of schizophrenia.

Detailed Description
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The study is a 12-week, double-blind, placebo-controlled, parallel group, randomized clinical trial of the efficacy of luteolin for the treatment of people with schizophrenia, who present with residual symptoms and cognitive impairments. The study will be conducted at two sites: The Maryland Psychiatric Research Center (MPRC) and the University of California Los Angeles (UCLA). Participants will be randomized to either 300mg BID luteolin (three 100mg capsules) or placebo. We hypothesize that luteolin will have significant beneficial effects on global psychopathology and cognitive impairments; decrease antioxidant stress and levels of inflammatory markers; and that improvement in global psychopathology and cognition will be associated with changes in the oxidative stress and inflammatory measures. We also hypothesize that luteolin will be associated with improvements in positive and negative symptoms of schizophrenia.

Official Title
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Luteolin for the Treatment of People With Schizophrenia

Conditions
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Schizophrenia, Schizoaffective Disorder

Intervention / Treatment
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* Dietary Supplement: Luteolin
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Either male or female of any race Age is 18-60 years old Meets DSM-5 criteria for schizophrenia or schizoaffective disorder 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 Clinically stable 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 Able to participate in the informed consent process and provide voluntary informed consent Exclusion Criteria: 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 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 Currently taking immunosuppressive medications (e.g. oral scheduled corticosteroids, chemotherapy or transplantation or HIV/AIDs associated drugs); or anti-inflammatory medications, including NSAIDs (e.g. ibuprofen, celecoxib, or naproxen) or aspirin > 81 mg on a daily basis. The use of PRN anti-inflammatory agents will be allowed. Female participants who are pregnant or nursing

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double-blind, placebo-controlled, parallel group, randomized clinical trial.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Luteolin<br> | Dietary Supplement: Luteolin<br>* The luteolin target dose will be 300 mg BID taken over 12 weeks in capsule form<br>* Other names: PureLut;|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* The placebo target dose will be 300 mg BID taken over 12 weeks in capsule form<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global psychopathology | To determine if luteolin is superior to placebo for the treatment of global psychopathology. | 12 weeks | 
| Cognitive impairments | To determine if luteolin is superior to placebo for the treatment of cognitive impairments. | 12 weeks | 
| Global oxidative stress | To determine if luteolin compared to placebo is associated with a decrease in the global measure of oxidative stress and/or a reduction in the levels of the inflammatory markers. | 12 weeks | 
| Cognition and oxidative stress | To determine if changes in symptom or cognitive measures are associated with changes in the global measure of oxidative stress and/or the levels of inflammatory markers | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive symptoms of schizophrenia | To determine if luteolin is superior to placebo for positive symptoms. | 12 weeks | 
| Negative symptoms of schizophrenia | To determine if luteolin is superior to placebo for negative symptoms. | 12 weeks |