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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
85
University of California, Los Angeles
Los Angeles, California, United States
Maryland Psychiatric Research Center
Baltimore, Maryland, United States
Global psychopathology
To determine if luteolin is superior to placebo for the treatment of global psychopathology.
Time frame: 12 weeks
Cognitive impairments
To determine if luteolin is superior to placebo for the treatment of cognitive impairments.
Time frame: 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.
Time frame: 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
Time frame: 12 weeks
Positive symptoms of schizophrenia
To determine if luteolin is superior to placebo for positive symptoms.
Time frame: 12 weeks
Negative symptoms of schizophrenia
To determine if luteolin is superior to placebo for negative symptoms.
Time frame: 12 weeks
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