Luteolin for the Treatment of People With Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 3
- 主要终点
- Cognition and oxidative stress
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Placebo
干预措施: Placebo (Dietary Supplement)
Luteolin
干预措施: Luteolin (Dietary Supplement)
结局指标
主要结局
Cognition and oxidative stress
时间窗: 12 weeks
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
Cognitive impairments
时间窗: 12 weeks
To determine if luteolin is superior to placebo for the treatment of cognitive impairments.
Global oxidative stress
时间窗: 12 weeks
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.
Global psychopathology
时间窗: 12 weeks
To determine if luteolin is superior to placebo for the treatment of global psychopathology.
次要结局
- Positive symptoms of schizophrenia(12 weeks)
- Negative symptoms of schizophrenia(12 weeks)
研究者
Deanna Kelly
Director, Maryland Psychiatric Research Center
University of Maryland, Baltimore