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| Name | Class |
|---|---|
| University of California, Los Angeles | OTHER |
| Stanley Medical Research Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Luteolin | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Luteolin | Dietary Supplement | The luteolin target dose will be 300 mg BID taken over 12 weeks in capsule form |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deanna Kelly, PharmD | University of Maryland, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles | Los Angeles | California | 90095 | United States | ||
| Maryland Psychiatric Research Center |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D047311 | Luteolin |
| ID | Term |
|---|---|
| D047309 | Flavones |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 |
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Double-blind, placebo-controlled, parallel group, randomized clinical trial.
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| Placebo | Dietary Supplement | The placebo target dose will be 300 mg BID taken over 12 weeks in capsule form |
|
| 12 weeks |
| Baltimore |
| Maryland |
| 21228 |
| United States |
| Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |