NMDA Modulation in Major Depressive Disorder
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 90
- 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. Therefore, this study will examine the efficacy and safety as well as cognitive function improvement of an NMDA enhancer (NMDAE) in the treatment of MDD in the adults.
详细描述
Major depressive disorder (MDD) is a complex and multi-factorial disorder. Most of the current antidepressants are based upon the monoamine hypothesis which cannot fully explain the etiology of depression. Many patients have significant side effects after treatment with antidepressants which hamper the motivation for treatment and medication adherence. 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. In our previous studies, cognitive improvement has been observed with treatment of NMDA enhancers. Therefore, this study will examine the efficacy and safety as well as cognitive function improvement of NMDAE in the treatment of MDD in the general adults by comparing with sertraline (a selective serotonin reuptake inhibitor [SSRI]) and placebo. The investigators will enroll non-elderly adult patients with MDD for an 8-week treatment. All patients will be randomly assigned into three groups: NMDAE, sertraline, or placebo. The investigators will biweekly measure clinical performances and side effects. Cognitive functions will be assessed at baseline and at endpoint of treatment by a battery of tests. The efficacy of three groups will be compared.
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 55 Years（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
- •17-item Hamilton Rating Scale for Depression total score ≥ 18
- •Free of antidepressant drugs for at least 2 weeks
- •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 depression, 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 severe adverse reaction to SSRIs
- •A treatment-resistant history (that is, they have failed to respond to two or more different classes of antidepressants with adequate dosage and treatment duration
- •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)
SSRI
Sertraline (selective serotonin reuptake inhibitor)
干预措施: Sertraline (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 Continuous Performance Test(week 0, 8)
- Change in Perceived Stress Scale(week 0, 2, 4, 6, 8)
- Clinical Global Impression(week 0, 2, 4, 6, 8)
- Visual Analogue Scale (VAS)(week 0, 2, 4, 6, 8)
- Digit Span(week 0, 8)
- Spatial Span(week 0, 8)
- Quality of life (SF-36)(week 0, 8)
- Wisconsin Card Sorting Test(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)