NMDA Modulation in Antidepressant Nonresponders With Major Depressive Disorder
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Global Assessment of Functioning
研究概览
简要总结
Most of the current antidepressants for major depressive disorder (MDD) are based upon the monoamine hypothesis which cannot fully explain the etiology of depression. NMDA hypofunction has been implicated in the pathophysiology of depression. This study aims to examine the efficacy and safety of an NMDA enhancer (NMDAE) in the treatment of antidepressant nonresponders with MDD.
详细描述
Major depressive disorder (MDD) is a multi-factorial disorder. Most of the current antidepressants are based upon the monoamine hypothesis which cannot fully explain the etiology of depression. Many patients respond poorly to antidepressants and suffer from side effects. NMDA hypofunction has been implicated in the pathophysiology of depression. MDD is often associated with cognitive deficits which are not necessarily recovered by current antidepressants. The NMDA receptor regulates synaptic plasticity, memory, and cognition. Therefore, this study aims to examine the efficacy and safety as well as cognitive function improvement of NMDAE in the treatment of antidepressant nonresponders with MDD. The investigators will enroll a total of 50 antidepressant nonresponders with MDD. All patients, continuing their originally ongoing treatment throughout the study period, will be randomly assigned into either of two treatment groups: NMDAE or placebo. We will biweekly measure clinical performances using 17-item Hamilton Rating Scale for Depression, Global Assessment of Function, Perceived Stress Scale, Visual Analogue Scale for pain, Clinical Global Impression, and side effects. Quality of life and cognitive functions will be assessed at baseline and at endpoint of treatment.
The efficacies of NMDAE and placebo will be compared. Chi-square (or Fisher's exact test) will be used to compare differences of categorical variables and t-test (or Mann-Whitney test if the distribution is not normal) for continuous variables between treatment groups. Mean changes from baseline in repeated-measure assessments will be assessed using the generalized estimating equation (GEE). All p values for clinical measures will be based on two-tailed tests with a significance level of 0.05.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a DSM-5 (American Psychiatric Association) diagnosis of MDD
- •Have failed to respond to at least one antidepressant with adequate dosage and treatment duration
- •Their original treatments should have been unchanged for at least 8 weeks. Some treatment-resistant patients (that is, having failed to respond to at least two different classes of antidepressants) who have started to refuse any antidepressant by themselves due to previous failure experience are also allowed, if they have already been antidepressant-free for at least 2 weeks
- •17-item Hamilton Rating Scale for Depression total score ≥ 18
- •Agree to participate in the study and provide informed consent
排除标准
- •Current substance abuse or history of substance dependence in the past 6 months
- •History of epilepsy, head trauma, stroke or other serious medical or neurological illness which may interfere with the study
- •Bipolar disorder, schizophrenia or other psychotic disorder
- •Moderate-severe suicidal risks
- •Severe cognitive impairment
- •Initiating or stopping formal psychotherapy within six weeks prior to enrollment
- •A history of previously received electroconvulsive therapy
- •Inability to follow protocol
研究组 & 干预措施
NMDAE
An NMDA enhancer
干预措施: NMDAE (Drug)
Placebo
Placebo
干预措施: Placebo Cap (Drug)
结局指标
主要结局
Change in Global Assessment of Functioning
时间窗: Week 0, 2, 4, 6, 8
Assessment of global improvement. Minimum value: 1, maximum value:100, the higher scores mean a better outcome.
Change in Hamilton Rating Scale for Depression
时间窗: week 0, 2, 4, 6, 8
Assessment of depressive symptoms Minimum value: 0, maximum value:52, the higher scores mean a worse outcome.
次要结局
- Visual Analogue Scale for pain(week 0, 2, 4, 6, 8)
- Visual Continuous Performance Test(week 0, 8)
- Spatial Span(week 0, 8)
- Clinical Global Impression(week 0, 2, 4, 6, 8)
- Wisconsin Card Sorting Test(week 0, 8)
- Digit Span(week 0, 8)
- Change Change in Perceived Stress Scalein Perceived Stress Scale(week 0, 2, 4, 6, 8)
- Quality of life (SF-36)(week 0, 8)
- Logical Memory Test of the Wechsler Memory Scale(week 0, 8)
- Category Fluency(week 0, 8)
- Trail Marking A(week 0, 8)
- WAIS-III Digit Symbol-Coding(week 0, 8)
- Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) V2.0(week 0, 8)