Sensoril® (Ashwagandha) - A Standardized Extract From a Medicinal Plant - (Withania Somnifera) for Cognitive Enhancement in Persons With Bipolar Disorder: A Parallel Group, Randomized Double Blind, and Placebo Controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change From Baseline in Digit-Span Score at 8 Weeks
研究概览
简要总结
The investigators hypothesis is that oral Sensoril® (as compared to placebo) will enhance cognitive abilities (specifically measures of attention, executive function, working memory, and visuospatial ability) in persons with bipolar disorder. Secondarily, the investigators hypothesize there will be secondary improvements in residual mood/anxiety symptoms, and metabolic indices, if impaired (fasting blood glucose and lipids).
The investigators aim to test these hypotheses by conducting a randomized, placebo controlled, add on treatment trial of Sensoril® (added to existing mood stabilizer treatment) recruiting 60 subjects with DSM IV-TR bipolar disorder for a period of 8 weeks. Measures of cognition, psychopathology and laboratory indices will be utilized for evaluating primary and secondary outcomes, along with safety assessments.
详细描述
OBJECTIVE:
To evaluate if Sensoril® treatment of persons with bipolar illness will improve their cognitive performance and if it will improve residual mood/anxiety symptoms and impaired metabolic indices.
RESEARCH PLAN:
We will conduct a randomized, placebo controlled, add on treatment trial of Sensoril® (added to ongoing prescribed pharmacological mood stabilizer) for a period of 8 weeks. Measures of cognition, psychopathology and laboratory indices will be utilized for evaluating primary and secondary outcomes, along with safety assessments.
METHODS:
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
- •DSMIV-TR diagnosis of Bipolar Disorder
- •Ages 18 to 65
- •Men or Women
- •8th grade education or greater
- •Able to provide competent written informed consent
- •Current main mood stabilizer and mood status (YMRS and MADRS scores less than or equal to 10) are stable for greater than or equal to 4 weeks by history.
排除标准
- •Medically unstable conditions
- •Known allergy to Sensoril® (or Ashwagandha)
- •Current cognitive decline is attributable to a diagnosis of dementia or other neurological disorder
- •Pregnant or lactating women
- •Mini-mental score (MMSE) less than or equal to 23
- •Currently receiving donepezil, rivastigamine, or galatamine, or memantine or any marketed agent for slowing memory loss in dementia
- •Abnormal clinical thyroid status
- •Currently (or within past 2 weeks) receiving St. John's Wort, Gingko or Omega-3
研究组 & 干预措施
1- Sensoril (Ashwagandha)
Sensoril (Ashwagandha) will be administered using random assignment at a dose of 250 mg/day, increasing to a dose of 500 mg/day by the second week.
干预措施: Sensoril (Drug)
2 - Placebo
Placebo will be administered using random assignment at a dose of 250 mg/day, increasing to a dose of 500 mg/day by the second week.
干预措施: Placebo (Other)
结局指标
主要结局
Change From Baseline in Digit-Span Score at 8 Weeks
时间窗: 8 week treatment
Cognition was assessed using tests developed by The Cognition Group-(TCG); London, UK; and Delaware, USA. Testing procedures and consistency was assured by the same staff-patient dyad, and a TCG staff person had previously trained the research staff (Chengappa et al, 2012). A comprehensive cognitive battery was assessed. Details of these cognitive tests are available at http://www.cogtest.com, and are also described in other studies (Harvey et al, 2007, Lindenmayer et al, 2011, Chengappa et al, 2012). However, the results for Digit span which assesses short term or working memory are presented. The raw scores for "digit span" ranges from a minimum of 2 to a maximum of 8. The Digit Span test measures working memory and the longer the span the better the cognition therefore the higher score is the better outcome.
次要结局
- Sensoril Treatment Will Secondarily Improve Any Residual Anxiety Symptoms(Baseline and 8 week treatment)
- Sensoril Treatment Will Secondarily Improve Any Residual Symptoms of Mania.(Baseline and 8 weeks treatment)
- Sensoril® Treatment Will Secondarily Improve Any Residual Depressive Symptoms(Baseline and 8 week treatment)
研究者
K.N. Roy Chengappa
Professor of Psychiatry
University of Pittsburgh