A Randomized add-on Trial of D-serine for Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Depression Severity
研究概览
简要总结
The glutamate system is emerging as target for the development of novel antidepressant medication, in particular compounds modulating the NMDA receptor. While the NMDA receptor antagonist ketamine is an effective option for many treatment-restistant patients, it is also accompanied by dissociative and cognitive effects and also bears the risk to develop addiction, side effects that are significantly restricting its clinical utility. There is now compelling evidence of the antidepressant potential of D-serine, a NMDAR co-agonist. Compared to ketamine, D-serine goes along without any psychotomimetic effects or other side effects and thus might be a prom-ising novel antidepressant.
This study represents the first randomized control trial to test the efficacy of D-serine as an adjuvant therapy in patients with depression and thereby adds to re-cent efforts to establish novel glutamatergic antidepressants. Besides clinical measures, this study also explores the biological mechanisms underlying D-serine's clinical effect.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-60
- •Inpatients with a diagnosis of MDD with a current moderate-to-severe episode (HAM-D score > 16) (7)
- •Treatment as usual (TAU) for depression. TAU for depression may include no treatment at all or standard pharmacotherapy (antidepressants and antipsychotics such as aripiprazole, risperidone or quetiapine) and / or psychotherapy.
- •Able to read and understand study procedures and participant's information
排除标准
- •Other primary psychiatric diagnoses than MDD such as substance use and psychotic disorders
- •Serious suicide attempts
- •Contradiction for MRI (no pacemaker, MRI incompatible metal implants or splinters in the body, past heart/head surgery, past stroke/brain injury, claustrophobia)
- •Pregnant or lactating women (pregnancy test)
结局指标
主要结局
Depression Severity
时间窗: Change from baseline HAM-D score at 6 weeks
measured with the Hamilton Depression Rating Scale (HAM-D)
次要结局
- Inflammation(Change from baseline interleukin 1 and 6 level at 6 weeks)
- Anxiety(Change from baseline STAI score at 6 weeks)
- Prefrontal glutamate concentration(Change from baseline glutamate level at 6 weeks)
- Stress level(Change from baseline cortisol level at 6 weeks)
- Neurocognition(Change from baseline VLMT score at 6 weeks)
- Anhedonia(Change from baseline SHAPS score at 6 weeks)
研究者
André Schmidt
Principal Investigator
Psychiatric Hospital of the University of Basel