A Double-Blind Placebo-Controlled Trial of a Sulforaphane Nutraceutical to Reduce the Symptoms of Schizophrenia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Change in Positive and Negative Syndrome Scale (PANSS) Score From the Start to the End of the Double-blind Treatment Phase
研究概览
简要总结
The purpose of this study is to determine if taking a sulforaphane nutraceutical versus a placebo will reduce symptoms of schizophrenia when used in addition to standard antipsychotic medications.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Capacity for written informed consent
- •Age 18-65 years, inclusive
- •Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnosis of schizophrenia or schizoaffective disorder as determined by the Structured Clinical Interview for DSM-5 Disorders (SCID-5)
- •Currently an outpatient at time of screening
- •Residual psychotic symptoms of at least moderate severity as evidenced by a Positive and Negative Syndrome Scale (PANSS) total score of 60 or higher AND one or more of the following: one or more PANSS positive symptom scores of 4 or higher; OR containing at least three positive or negative items with scores of 3 or higher at the screening visit
- •Receiving antipsychotic medication for at least 8 weeks prior to enrolling in the study with no antipsychotic medication changes within the previous 21 days from visit 2 (week 0)
- •Conformance to PORT Treatment Recommendation about Maintenance Antipsychotic Medication Dose
- •Proficient in the English language
- •Participated previously in one of our screening studies
排除标准
- •Any clinically significant or unstable medical disorder as determined by the principal investigator and/or the study physician (e.g., HIV infection or other immunodeficiency condition (such as receiving chemotherapy), uncontrolled diabetes, congestive heart failure)
- •DSM-5 diagnosis of intellectual disability or comparable diagnoses determined by previous versions of the DSM
- •DSM-5 diagnosis of a moderate or severe substance use disorder, except for caffeine or tobacco, within the last three months prior to the screening visit. If the patient has a positive drug toxicity screen at the time of visit 1 (screening), further evaluation by the investigator will be done of the substance use to determine eligibility.
- •Any current use of a broccoli supplement (e.g., Avmacol® or other health food broccoli supplement)
- •Participated in any investigational drug trial in the past 30 days prior to the screening visit
- •Pregnant, planning to become pregnant, or breastfeeding during the study period
研究组 & 干预措施
Sulforaphane Nutraceutical
The sulforaphane nutraceutical contains inactive glucoraphanin, a glucosinolate from broccoli seeds, and myrosinase from broccoli sprouts. The ingestion of this compound leads to the hydrolysis of glucoraphanin, the generation of sulforaphane within the gastrointestinal (GI) tract, and the subsequent systemic absorption of the sulforaphane. The dose per tablet is 16 mg of glucoraphanin or 37 µmol; 6 tablets per day should yield about 100 µmol of sulforaphane. The tablets, which will be swallowed, are provided as .375 punch size, round concave tablets. In this arm, the participant will take 6 tablets of the sulforaphane nutraceutical daily for 16 weeks after a 2-week placebo run-in.
干预措施: Sulforaphane Nutraceutical (Drug)
Identical-appearing Placebo
The inert compound placebo looks identical to the sulforaphane nutraceutical. In this arm, the participant will take 6 tablets of the placebo daily for 16 weeks after a 2-week placebo run-in.
干预措施: Identical-appearing Placebo (Drug)
结局指标
主要结局
Change in Positive and Negative Syndrome Scale (PANSS) Score From the Start to the End of the Double-blind Treatment Phase
时间窗: 16 weeks (week 2 to week 18)
The Positive and Negative Syndrome Scale (PANSS) measures psychiatric symptomatology, especially related to psychosis. The complete PANSS contains ratings for 30 symptoms, including 7 positive symptoms, 7 negative symptoms, and 16 general psychiatric symptoms. The severity of each symptom is rated on a scale ranging from 1 (minimal) to 7 (extreme); higher scores indicate increased symptomatology. Total PANSS scores include scores from all categories and range from 30 to 210 units on a scale.
次要结局
- Change in C-Reactive Protein From the Start to the End of the Study(18 weeks (assessed at weeks 0, 10, and 18; weeks 0 and 18 reported))
- Change in Interleukin-6 From the Start to the End of the Study(18 weeks (assessed at weeks 0, 10, and 18; weeks 0 and 18 reported))
- Change in Tumor Necrosis Factor - Alpha From the Start to the End of the Study(18 weeks (assessed at weeks 0, 10, and 18; weeks 0 and 18 reported))
- Change in Anti-Saccharomyces Cerevisiae IgA Class Antibodies From the Start to the End of the Study(18 weeks (assessed at weeks 0, 10, and 18; weeks 0 and 18 reported))
- Change in Interferon Gamma From the Start to the End of the Study(18 weeks (assessed at weeks 0, 10, and 18; weeks 0 and 18 reported))
- Change in MATRICS Consensus Cognitive Battery (MCCB) Overall Composite Scores From the Start to the End of the Study(18 weeks (week 0 to week 18))
- Change in Pentraxin-3 From the Start to the End of the Study(18 weeks (assessed at weeks 0, 10, and 18; weeks 0 and 18 reported))
研究者
Faith Dickerson
Principal Investigator, Stanley Research Program
Sheppard Pratt Health System