A Pilot Add-on Randomized, Placebo Controlled Intervention Trial of Cognitive Enhancement in Persons With Bipolar Disorder Using an Antioxidant and Advanced Glycation End (AGE) Product Inhibitor: L-Carnosine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 3
- 主要终点
- That L-carnosine treatment of persons with bipolar illness will improve their cognitive outcomes, specifically, measures of attention and executive function, verbal and visuospatial memory and psychomotor performance, relative to placebo treatment.
研究概览
简要总结
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 bipolar disorder. Secondarily, we hypothesize there will be secondary improvements in positive, negative and mood symptoms with L-carnosine treatment.
We aim to test these hypotheses by conducting a randomized, placebo controlled, add on treatment trial of L-carnosine (added to existing antipsychotic treatment) on 48 recruited subjects with DSM IV TR bipolar disorder for a period of 12 weeks. Measures of cognition, and psychopathology will be utilized for evaluating primary and secondary outcomes, along with safety assessments.
详细描述
OBJECTIVE:
It is our hypothesis that L-carnosine treatment of persons with bipolar illness will improve their cognitive outcomes, more specifically, measures of attention and executive function, verbal and visuospatial memory and psychomotor performance, relative to placebo treatment. We also hypothesize that L-carnosine treatment may secondarily improve any residual affective symptoms.
RESEARCH PLAN:
We aim to test these hypotheses by conducting a randomized, placebo controlled, add on treatment trial of L-carnosine (added to ongoing prescribed pharmacological treatment, for example - lithium, anticonvulsants, antipsychotic agents and depressants) for a period of 12 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 bipolar I disorder or
- •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 medication and mood status (Y-MRS and MADRS scores less than or equal to 10) 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, including HIV dementia or cognitive decline
- •Pregnant or lactating women
- •Mini-mental state examination score (MMSE) less than or equal to 23.
研究组 & 干预措施
L- Carnosine
an antioxidant and AGE inhibitor, 500 mg/day, increasing each week in titration reaching 2000 mg/day in 4 weeks and maintained for rest of trial
干预措施: L-carnosine (Drug)
Placebo
Placebo
干预措施: L-carnosine (Drug)
结局指标
主要结局
That L-carnosine treatment of persons with bipolar illness will improve their cognitive outcomes, specifically, measures of attention and executive function, verbal and visuospatial memory and psychomotor performance, relative to placebo treatment.
时间窗: 12 weeks treatment
次要结局
- That L-carnosine treatment may secondarily improve any residual affective symptoms in subjects with bipolar disorder.(12 weeks treatment)
研究者
K.N. Roy Chengappa
Professor of Psychiatry
University of Pittsburgh