The Effect of D-serine as add-on Therapy in Recent-onset Psychosis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Total symptom severity
研究概览
简要总结
In psychotic disorders, negative symptoms and cognitive impairment are difficult to treat with antipsychotics, which are mostly effective for positive symptoms. However, it is important that negative symptoms and cognitive impairment are treated as well, as they both play a large part in the acute episode and long-term course of schizophrenia outcome. Previous studies have used D-serine as add-on treatment in patients with psy-chotic disorders and high-risk patients, with positive results. So far, no study has investigated the effects in a sample of recent-onset psychosis patients.
Therefore, this study will include 30 patients (18-50 years old) with recent-onset psychosis. In addition to their regular treatment, patients will receive either D-serine (2 g/d) or placebo for 6 weeks. D-serine is an amino-acid naturally occurring in the brain which is prescription-free available as nutritional supplement.
The primary outcome measure is total score on the Positive and Negative Syndrome Scale (PANSS). Secondary measure-ments include PANSS subscales, neurocognitive tests, (f)MRI, and EEG
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-50
- •Recent onset psychosis (< 5 years of overt psychotic symptoms)
- •Able to read and understand study procedures and participant's information
排除标准
- •Clozapine use
- •Suicidal ideation
- •Psychotic disorders and symptoms associated with general medical conditions or substance abuse
- •BMI > 30
- •Renal impairment (history and creatin levels (< 80 ug/L for woman and < 97 ug/L for men))
- •Hearing impairment
- •Current or past (< 6 months) enrolment in another clinical trial with the primary outcome to improve symptoms
- •Pregnant or lactating women (pregnancy test)
结局指标
主要结局
Total symptom severity
时间窗: change from baseline to 6 weeks
total score on the Positive and Negative Syndrome Scale (PANSS). Lower scores indicate better outcome (min. 30 - max. 120).
次要结局
- Subscales symptom severity(change from baseline to 6 weeks)
- Executive functioning(change from baseline to 6 weeks)
- Mismatch Negativity (MMN)(change from baseline to 6 weeks)
- Attention and processing speed(change from baseline to 6 weeks)
- Memory(change from baseline to 6 weeks)
- Resting-state microstates(change from baseline to 6 weeks)
- Intelligence(change from baseline to 6 weeks)
- Symptom severity and treatment response(change from baseline to 6 weeks)
研究者
Dragos Inta
Prof. Dr. med.
Psychiatric Hospital of the University of Basel