L-Carnosine, an Antioxidant and AGE Inhibitor (Advanced Glycation End Products) for Cognitive Enhancement Among Persons With Schizophrenia: A Randomized, Add-on Double-Blind, Placebo Controlled, Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 4
- 主要终点
- To see if oral L-carnosine treatment (as compared with placebo) will enhance cognitive abilities (as noted below)
研究概览
简要总结
The investigators' hypothesis is that oral L-carnosine treatment (as compared with placebo) will enhance cognitive abilities (specifically: measures of attention, executive function, working memory, visuospatial ability and language) in persons with schizophrenia or schizoaffective disorder. Secondarily, they hypothesize that there will be secondary improvements in positive, negative and mood symptoms with L-carnosine treatment.
The investigators aim to test these hypotheses by conducting a randomized, placebo controlled, add-on treatment trial of L-carnosine (added to existing antipsychotic treatment) up to 84 recruited subjects with Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) schizophrenia/schizoaffective disorder for a period of 16 weeks. Measures of cognition and psychopathology will be utilized for evaluating primary and secondary outcomes, along with safety assessments.
详细描述
OBJECTIVE:
Based on the available neuroscience and human data, we hypothesize that supplemental L-carnosine treatment (a potent naturally occuring antioxidant and anti-glycation agent) will be a useful disease modifying agent when used adjunctively with antipsychotic drugs in patients with a diagnosis of either schizophrenia or schizoaffective disorder. More specifically, our hypothesis is that oral L-carnosine treatment (as compared with placebo) will enhance cognitive abilities (specifically: measures of attention, executive function, working memory, visuospatial ability and language) in persons with schizophrenia or schizoaffective disorder. Secondarily, we hypothesize there will be secondary improvements in positive, negative and mood symptoms with L-carnosine treatment.
RESEARCH PLAN:
A randomized, placebo controlled, add-on treatment trial of L-carnosine (added to existing antipsychotic treatment) for a period of 16 weeks. Measures of cognition, and psychopathology 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
- •DSM-IV-TR diagnosis of schizophrenia (any subtype, except currently catatonic) or schizoaffective disorder
- •Ages 18 to 65 years
- •Men or women
- •Ability to read and communicate in English
- •8th grade education or greater
- •Ability to provide informed, competent and written consent
- •Current antipsychotic medication is stable for greater than or equal to 4 weeks.
排除标准
- •Medically unstable conditions
- •Known allergy to L-carnosine
- •Current cognitive decline is attributable to a diagnosis of dementia or other neurological disorder
- •Pregnant or lactating women
- •Mini-mental state examination score (MMSE) less than or equal to 23
- •HIV positive status resulting in AIDS-related dementia.
研究组 & 干预措施
1
L Carnosine
干预措施: L-carnosine (dietary supplement) (Drug)
2
Placebo
干预措施: L-carnosine (dietary supplement) (Drug)
结局指标
主要结局
To see if oral L-carnosine treatment (as compared with placebo) will enhance cognitive abilities (as noted below)
时间窗: 12 weeks treatment
executive function, working memory, attention, visuospatial ability
时间窗: 12 weeks treatment
次要结局
- To examine if secondary improvements in positive, negative and mood symptoms occur with L-carnosine treatment(12 weeks treatment)