D-SERINE TREATMENT FOR TARDIVE DYSKINESIA
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Change in AIMS total score
研究概览
简要总结
Presently no generally effective treatments for tardive dyskinesia (TD) are available. D-serine is a naturally occurring amino acid that acts in-vivo as positive allosteric modulator at the glycine site associated with the glutamatergic NMDA receptor. Previous studies have suggested that D-serine may improve motor symptoms, including dyskinesias, which are caused by treatment with presently used antipsychotics drugs.
The hypothesis under investigation in the present study is that D-serine adjuvant treatment may improve TD in schizophrenia patients diagnosed with this disorder.
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
- Triple (Participant, 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
- •diagnosis of schizophrenia/schizoaffective disorder according to DSM-IV criteria; diagnosis will be made on the basis of SCID interview and information from medical records, previous treating psychiatrists, and family informants;
- •history of ≥3 months antipsychotic drugs treatment and present stable dose antipsychotic treatment for at last 4 weeks;
- •fulfillment of Schooler-Kane TD research criteria on a first evaluation performed 2-12 weeks prior to study entrance and on a subsequent evaluation performed prior to allocation to experimental treatment.
排除标准
- •meeting criteria for other DSM-IV Axis I diagnoses;
- •presence of a neurological disorder or history of significant head injury;
- •substance abuse or alcoholism during entire lifetime;
- •are judged clinically to be at suicidal or homicidal risk;
- •female patients who are pregnant or lactating; female patients who are not pregnant or lactating, if sexually active, must be using medically accepted means of contraception.
研究组 & 干预措施
Placebo adjuvant treatment
Random assignment, parallel group, double blind, placebo controlled 8 weeks trial.
First arm: D-serine adjuvant treatment, up to 4 g/day Second arm: Placebo adjuvant treatment
干预措施: Placebo (Dietary Supplement)
D-serine adjuvant treatment
Random assignment, parallel group, double blind, placebo controlled 8 weeks trial.
First arm: D-serine adjuvant treatment, up to 4 g/day Second arm: Placebo adjuvant treatment
干预措施: D-serine (Dietary Supplement)
结局指标
主要结局
Change in AIMS total score
时间窗: biweekly during a period of 8 weeks
次要结局
未报告次要终点
研究者
Heresco-Levi Uriel
Director - Psychiatry Department
Herzog Hospital