NCT01391390已完成不适用
The Effect of Melatonin Treatment on Tardive Dyskinesia and Oxidative Stress: A Double-Blind Placebo-Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- the Abnormal Involuntary Movement Scale (AIMS)
研究概览
简要总结
This is a double-blind, randomized, placebo-controlled trial of melatonin as an add-on therapy to antipsychotics will be performed to examine the effects of melatonin on tardive dyskinesia symptoms and cognitive deficits in 120 patients with established tardive dyskinesia (TD). This study addresses a free radical hypothesis of TD.
详细描述
- Since it has been proposed that neuroleptic-induced increases in free-radical production may relate to the development of TD, the investigators hypothesize that melatonin, an effective antioxidant, may attenuate the severity of tardive dyskinesia symptoms.
- Due to increased cognitive deficits in patients with TD and implication of oxidative stress in cognitive impairment, the investigators hypothesize that both cognitive impairment and tardive dyskinesia symptoms may be induced by the same pathophysiological stimulus--oxidative stress. Hence, the investigators further hypothesize that both tardive dyskinesia symptoms and cognitive deficits in patients with TD may be improved by melatonin simultaneously.
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
- Double (Participant, Investigator)
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
- •diagnosis of both schizophrenia and TD;
- •duration of TD symptoms longer than 1 year;
- •on stable doses of antipsychotic drug for at least 6 months;
- •between 18 and 70 years of age.
排除标准
- •comorbid neurological illness other than TD;
- •if they have received vitamin C or vitamin E within 1 month before the start of the study;
- •alcohol/drug abuse;
- •acute, unstable medical condition;
- •pregnant or breastfeeding female;
- •use of other antioxidants.
研究组 & 干预措施
Melatonin, antioxidant, oxidative stress
Experimental
Melatonin is an active treatment for TD.
干预措施: Melatonin (Drug)
Placebo
Placebo Comparator
Placebo look like the active drug, and same dose.
干预措施: Placebo (Drug)
结局指标
主要结局
the Abnormal Involuntary Movement Scale (AIMS)
时间窗: 12 weeks
次要结局
- the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)(12 weeks)
- the Positive and Negative Syndrome Scale (PANSS)(12 weeks)
- the Simpson-Angus Scale for extrapyramidal side effects (SAS)(12 weeks)
研究者
Xiang Yang Zhang
Director, Biological Psychiatry Center
Beijing HuiLongGuan Hospital
研究点 (1)
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