Adjunctive Withania Somnifera (Ashwagandha) for Persistent Symptoms in People With Schizophrenia
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Positive and Negative Symptom Scale
研究概览
简要总结
To determine whether a standardized extract of Withania somnifera will reduce psychopathology scores (PANSS total score) in persons with schizophrenia. A secondary aim is to determine whether WSE reduces measures of positive and negative symptoms (PANSS subscales) and stress scores on the Perceived Stress Scale (PSS).
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnostic and Statistical Manual (DSM) 5 diagnosis of schizophrenia or schizoaffective disorder
- •Ability to provide informed written consent
- •PANSS total score ≥ 70 or a CGI Severity Scored ≥ 4; and at least 2 positive symptom subscale items (i.e., delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility and unusual thought content) scoring ≥ 4, or one of these items scoring ≥ 5, on a scale ranging from 1 = absent to 7 = extreme.
- •Evidence of a positive symptom exacerbation during the year prior to study entry.
- •For women of child bearing age, a negative serum pregnancy test at screening
排除标准
- •Testing positive for illicit substances (positivity to marijuana or opioids will be assessed on a case by case basis due to the long elimination half life in the urine of marijuana and the use of opioids for various pain disorders, caffeine and nicotine are excepted)
- •Receiving pharmacological treatment for addictions (naltrexone, suboxone, acamprosate, others) will be reviewed on a case by case basis
- •Seriously unstable medical illnesses
- •Pregnant or breast feeding women
- •Known allergy or history of serious adverse event with WSE
- •Subjects who may require imminent hospitalization (examples: suicidal or aggressive behavior)
- •Currently receiving antibiotics, anti-viral, or anti-parasitic medications
- •Currently receiving immunosuppressive medications (e.g. oral scheduled corticosteroids, chemotherapy or transplantation or HIV/AIDS associated drugs).
研究组 & 干预措施
Withania Somnifera Extract (WSE)
WSE 500 mg bid for 12 weeks
干预措施: WSE (Drug)
Placebo tablets
Placebo oral tablet bid for 12 weeks
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Positive and Negative Symptom Scale
时间窗: 12 weeks
The Positive and Negative Syndrome Scale (PANSS) is a medical scale used for measuring symptom severity of patients with schizophrenia. To assess a patient using PANSS, an approximately 45-minute clinical interview is conducted. The patient is rated from 1 to 7 on 30 different symptoms based on the interview as well as reports of family members or primary care hospital workers. Subjects can not score lower than 30 or higher than 210. Higher score indicates higher amount of psychopathology
次要结局
- PANSS Negative Factor Score Also Know as Marder Factors(12 weeks)
研究者
Stephen Marder
Professor
University of California, Los Angeles