Coenzyme Q10 in the Amelioration of Cognitive Deficits and Symptoms in Schizophrenia and Schizoaffective Disorder
试验速览
- 阶段
- 不适用
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Change from baseline attention
研究概览
简要总结
The study is a randomised placebo controlled trial of Coenzyme Q10 (CoQ10) vitamin supplementation in a sample of patients with schizophrenia or schizoaffective disorder. CoQ10 is produced in the mitochondria of our cells, and is involved in the production of energy. However, some people do not produce enough CoQ10, which can result in difficulties with concentration and memory, depressive symptoms, low energy levels and high blood pressure. The study will examine the impact of taking oral CoQ10 supplementation on patients with schizophrenia and schizoaffective disorder.
详细描述
Coenzyme-Q10 (CoQ10) is an essential cofactor in the mitochondrial electron-transport-chain in addition to being a potent lipophilic antioxidant. Deficits in CoQ10 status have been linked to cardiovascular disease, cognitive decline, fatigue, and depression. CoQ10 supplementation may have a potential therapeutic value for patients with schizophrenia and schizoaffective disorder. This is a double-blind, placebo-controlled, randomised trial that will compare neurocognitive performance and symptoms of schizophrenia and schizoaffective disorder in participants randomised to active CoQ10 compared to scores from participants who received placebo. CoQ10 will be administered at a dose of 300mg/day, delivered in 3 doses of 100mg each. Participants will take CoQ10/placebo for 6 months. At three time points (baseline, 3 months and 6 months) each participant completes a neurocognitive and psychological battery of assessments. Blood pressure is monitored, and blood samples to assess mitochondrial function and plasma CoQ10 status are taken at each assessment.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of schizophrenia or schizoaffective disorder
排除标准
- •Current substance abuse
- •History of epilepsy/seizures
- •Head injury with loss of consciousness (>3 minutes)
- •Taking warfarin or blood thinning medication
- •Uncontrolled thyroid dysfunction
研究组 & 干预措施
Coenzyme Q10
100mg CoQ10 capsule taken orally three times per day for 6 months
干预措施: Coenzyme Q10 (Dietary Supplement)
Placebo
Placebo capsule taken orally three times per day for 6 months
干预措施: Placebo (Other)
结局指标
主要结局
Change from baseline attention
时间窗: 6 months post-supplementation initiation/Directly following study treatment period
Change from baseline attention as measured by Continuous Performance Test, identical pairs version (CPT-IP)
Change from baseline working memory performance
时间窗: 6 months post-supplementation initiation/Directly following study treatment period
Change from baseline working memory performance as measured by Cambridge Neuropsychological Test Automated Battery (CANTAB) spatial working memory task.
次要结局
- Change from baseline depression levels(6 months post-supplementation initiation/Directly following study treatment period)
- Change from baseline anxiety levels(6 months post-supplementation initiation/Directly following study treatment period)
- Change from baseline negative symptoms of avolition, asociality, blunted affect and alogia levels(6 months post-supplementation initiation/Directly following study treatment period)
- Change from baseline blood pressure (systolic and diastolic)(6 months post-supplementation initiation/Directly following study treatment period)
- Change from baseline plasma CoQ10 levels(6 months post-supplementation initiation/Directly following study treatment period)
- Change from baseline mitochondrial function(6 months post-supplementation initiation/Directly following study treatment period)
- Change from baseline energy levels(6 months post-supplementation initiation/Directly following study treatment period)
- Change from baseline processing speed(6 months post-supplementation initiation/Directly following study treatment period)
研究者
Michael Gill, MD
Professor
University of Dublin, Trinity College