An Exploratory Open Label Study of Adjunctive L-lysine Treatment in Patients With Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Psychotic symptoms severity
研究概览
简要总结
The objective of the present study was to investigate the possibility of using L-lysine, an amino acid that occurs naturally in food and which interferes with nitric oxide (NO) production, for the treatment of schizophrenia. L-lysine, 6 g/day, was administered to ten patients with schizophrenia as an add-on treatment to conventional antipsychotic treatment. The study was designed as a single-blinded, cross-over study where patients were randomly assigned to initial treatment with either L-lysine or placebo and screened at baseline, after four weeks when treatment was crossed over, and after eight weeks when treatment was terminated. The four-week L-lysine treatment regimen caused a significant increased in blood concentration of the amino acid and was tolerated well. The analysis of outcome measures showed a significant decrease in symptom severity as measured by the Positive and Negative Syndrome Scale (PANSS). Furthermore, the patient's ability to solve the Wisconsin Card Sorting Task (WCST) was significantly improved indicating increased problem solving capacity and cognitive flexibility. Subjective reports from three of the patients also indicated decreased symptom severity and enhanced cognitive functioning. In summary, these findings suggest potential beneficial effects of L-lysine treatment on symptom severity and cognitive deficits in patients with schizophrenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 23 Years 至 56 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a stable phase of illness
- •a stable dose of antipsychotic medication
- •no other major medical conditions or other psychiatric diagnosis
- •normal admission laboratory tests and vital signs
排除标准
- •substance abuse, apart from smoking
研究组 & 干预措施
L-lysine
干预措施: L-lysine (Drug)
结局指标
主要结局
Psychotic symptoms severity
时间窗: Eight weeks
次要结局
- Treatment safety assessment(Eight weeks)
