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临床试验/NCT02476708
NCT02476708终止不适用

A Pilot Trial of Curcumin Effects on Cognition in Schizophrenia

Yale University2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2016年2月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
12
试验地点
2
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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Curcumin 1800mg

Experimental

curcumin capsule 600mg taken 3 times per day for 8 weeks

干预措施: curcumin 1800mg (Dietary Supplement)

Placebo

Placebo Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cenk Tek

Associate Professor of Psychiatry

Yale University

研究点 (2)

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