A Pilot Trial of Curcumin Effects on Cognition in Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Efficacy of curcumin (MATRICS - Composite Score t score)
研究概览
简要总结
This is an 8-week randomized, double-blind, placebo-controlled, parallel, fixed-dose pilot clinical trial of curcumin for the treatment of cognitive impairment in schizophrenia.The primary aim of this pilot trial is to provide an effect size estimate for the efficacy of curcumin in improving cognitive functioning in schizophrenia. Secondary goals are to determine the effect of curcumin over time on negative and positive symptoms, in association with inflammatory markers.
详细描述
This is an 8-week randomized, double-blind, placebo-controlled, parallel, fixed-dose pilot clinical trial of curcumin for the treatment of cognitive impairment in schizophrenia. Cognitive impairment and persistent negative symptoms are the core dimensions of schizophrenia; however current antipsychotic treatment fails to address this issue. Evidence suggests cognitive impairment is not only limited to patients with late-stage schizophrenia. High rates of cognitive impairment in patients with first episode psychosis indicate that cognitive impairment is not solely a consequence of long-term antipsychotic treatment, but rather is an enduring problem over the course of schizophrenia. Likewise, negative symptoms persist throughout its entire course, and are associated with poor overall functioning. Currently, there are no pharmacological agents that specifically aim to treat cognitive functioning and persistent negative symptoms; therefore, there is growing interest in the development of effective treatments for this unmet need.
The primary aim of this pilot trial is to provide an effect size estimate for the efficacy of curcumin in improving cognitive functioning in schizophrenia. Secondary goals are to determine the effect of curcumin over time on negative and positive symptoms, in association with inflammatory markers. Eligible participants will be randomized to curcumin (n=20) or placebo (n=20) in a 1:1 ratio. A commercially available surface-controlled water soluble form of 600mg curcumin (10% formulation) or matching placebo capsules will be administered three times a day for a total of 8 weeks.
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
- •18 - 65 years of age
- •English speaking
- •Diagnostic and Statistical Manual- IV diagnosis of schizophrenia or schizoaffective disorder based on Structured Clinical Interview for Diagnostic and Statistical Manual-IV (SCID)
- •Symptomatic stability confirmed by clinical staff in the 8 weeks prior to the study
- •No changes in antipsychotic medication within the last 8 weeks
- •No change in antipsychotic dose in in last 4 weeks.
排除标准
- •Unable to provide informed consent
- •Diagnostic and Statistical Manual-IV (DSM-IV) diagnosis of alcohol/substance dependence
- •Recent history of gastrointestinal bleeding or ulceration
- •Recent history of gallstones and/or bile duct obstruction
- •Significant uncontrolled systemic illness (e.g. chronic renal failure, chronic liver disease, poorly controlled diabetes, poorly controlled congestive heart failure, chronic infectious disease, chronic autoimmune disease)
- •Known intolerance to turmeric, curcumin, or curry
- •Pregnancy or breast-feeding
- •Current use of anti-platelet, anti-coagulant, glucocorticoid, immunosuppressants
- •Daily use of non-steroidal anti-inflammatory use.
研究组 & 干预措施
Curcumin 1800mg
curcumin capsule 600mg taken 3 times per day for 8 weeks
干预措施: curcumin 1800mg (Dietary Supplement)
Placebo
placebo capsule taken 3 times per day for 8 weeks
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Efficacy of curcumin (MATRICS - Composite Score t score)
时间窗: 8 weeks
The primary outcome will estimate the efficacy of curcumin in improving cognitive functioning in schizophrenia. This would be measured by comparing change in cognition scores (MATRICS Consensus Cognitive Battery Composite Score) between baseline and endpoint based on medication assignment.
次要结局
- Efficacy of curcumin (MATRICS - Attention/Vigilance t-score)(8 weeks)
- Efficacy of curcumin (MATRICS - Visual Learning t-score)(8 weeks)
- Efficacy of curcumin (MATRICS - Speed of Processing - t score)(8 weeks)
- Efficacy of curcumin (MATRICS - Reasoning and Problem Solving t-score)(8 weeks)
- Efficacy of curcumin (MATRICS - Working Memory t-score)(8 weeks)
- Efficacy of curcumin (MATRICS - Verbal Learning t-score)(8 weeks)
- Effect on psychiatric symptoms (PANSS - Positive Score)(8 weeks)
- Effect on psychiatric symptoms (PANSS- Negative Score)(8 weeks)
- Effect on psychiatric symptoms (PANSS- Total Score)(8 weeks)
- Efficacy of curcumin (MATRICS - Social Cognition t-score)(8 weeks)
研究者
Cenk Tek
Associate Professor of Psychiatry
Yale University