Curcumin as a Novel Treatment to Improve Cognitive Dysfunction in Schizophrenia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
研究概览
简要总结
The investigators propose to test whether curcumin nanoparticles will improve behavioral measures and biomarkers of cognition and neuroplasticity in patients with schizophrenia who are already receiving a stable dose of antipsychotic.
详细描述
The investigators will use a formulation of curcumin with high bioavailability that possesses a pharmacokinetic profile expected to exert biological effects. Specifically, 36 subjects will be enrolled in the double-blind randomized controlled trial. They will be randomized to curcumin or placebo for 8 weeks. At baseline, and 4 and 8 weeks, subjects will receive assessments of neurocognition (e.g., processing speed, attention and vigilance, working memory, learning, reasoning and problem solving), social cognition, EEG biomarkers (e.g., visual cortical plasticity and mismatch negativity), a serum marker of neurogenesis (BDNF levels), and clinical symptoms (positive and negative symptoms). At weeks 2 and 6 subjects will return for additional safety (e.g., vitals, side effects, akathisia) and medication adherence assessments. Improvement on the primary outcome measure (MATRICS Consensus Cognitive Battery), as well as secondary outcome measures, will be compared between participants randomized to placebo versus curcumin. The results of this study will establish whether curcumin is a viable adjunctive agent for future larger clinical trials.
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
- •DSM-5 diagnosis of schizophrenia
- •age 18 - 65 years
- •understand spoken English sufficiently to comprehend testing procedures
- •corrected vision of at least 20/30
- •currently prescribed an antipsychotic medication
排除标准
- •clinically significant neurological disease determined by medical history (e.g., epilepsy)
- •history of serious head injury (i.e., loss of consciousness > 1 hr., no neuropsychological sequelae, no cognitive rehabilitation post head injury)
- •sedatives or benzodiazepines within 12 hrs of testing
- •any psychiatric hospitalization within 3 months prior to study participation
- •behaviors suggesting any potential danger to self or others within 6 months prior to study participation
- •antipsychotic dose change more than 50% over the 3 months prior to study participation
- •acute medical problems or untreated chronic medical conditions within 3 months prior to study participation
研究组 & 干预措施
Sugar Pill
Matched placebo, 2 capsules twice daily.
干预措施: Placebo (Drug)
Curcumin
Curcumin capsules (Theracurmin formulation of curcumin nanoparticles). Subjects randomized to curcumin will receive 360 mg/day (divided into twice daily oral doses).
干预措施: Curcumin (Drug)
结局指标
主要结局
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
时间窗: Baseline, Week 4, Week 8
This battery was developed as part of the National Institute of Mental Health (NIMH) sponsored Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Initiative to assess cognition in clinical trials of cognition enhancing drugs. The MCCB comprises 10 tests that assess 7 cognitive domains (speed of processing, verbal memory, visual memory, working memory, reasoning and problem solving, attention/vigilance, and social cognition). The MCCB takes approximately 65 minutes to administer and provides age and gender-corrected normed T-scores, including a global composite score and cognitive domain scores. The range of T-scores is between 0 to 100 with a mean of 50. Higher scores indicate better overall cognitive functioning.
次要结局
- Electroencephalogram (EEG) Mismatch Negativity Paradigm (MMN)(Baseline, Week 4, Week 8)
- Brain Derived Neurotrophic Factor (BDNF)(Baseline, Week 4, Week 8)
- Brief Psychiatric Rating Scale (BPRS)(Baseline, Week 4, Week 8)
- The Clinical Assessment Interview for Negative Symptoms (CAINS)(Baseline, Week 4, Week 8)
研究者
Michael C. Davis, M.D., Ph.D.
Physician
VA Greater Los Angeles Healthcare System