Study on the Optimal Diagnosis and Treatment Strategy of Major Depressive Disorder Based on Anhedonia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 252
- 试验地点
- 3
- 主要终点
- 17-item Hamilton depression rating scale (HAMD-17) value
研究概览
简要总结
This study is a multicenter clinical research and focuses on the exploring of optimal diagnosis and treatment strategies of MDD based on anhedonia.
详细描述
Major depressive disorder (MDD) is a heterogeneious psychiatric disorder with complex etiology and pathogenesis. The lack of objective criteria for diagnosis and the use of trial-and-error treatment strategy are the current challenge. Anhedonia is the core symptom of MDD and the aberrant reward system and abnormal inflammatory immune may be the pathological mechanisms. Previous evidence suggests anhedonia cannot be improved quickly and efficiently by taking the first-line antidepressants. This study focuses on exploring the optimal diagnosis and treatment strategy for MDD patients with anhedonia. Based on the hypothesis of inflammatory-immune system，neurotransmitter abnormalities and aberrant reward system, this study aims to evaluate the efficacy and safety of the combinations of escitalopram and aripiprazole and/or omega-3 polyunsaturated fatty acids for MDD patients with anhedonia with a factorial design. Moreover, the multidimensional data including the clinicopathological features, neuroimaging data (MRI) and inflammatory cytokines will be used to establish the model of diagnosis and treatment strategy.
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
- Single (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
- •Major depressive disorder according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5);
- •Age: 18-55 (including 18 and 55)
- •Do not receive repetitive Transcranial Magnetic Stimulation (rTMS) or modified electroconvulsive therapy (MECT) treatment in past six months.
- •Sign the informed consent form voluntarily and agree to participate in all visits, examinations and treatment as required by the trial protocol.
排除标准
- •Patients who are diagnosed with major somatic diseases;
- •Patients who meet DSM-5 diagnostic criteria for other mental disorders: Personality disorder, mental retardation; drug and/or alcohol dependence;
- •Patients with severe suicidal tendencies or suicidal behavior;
- •Pregnant or lactating women;
- •Patients with MRI contraindications;
- •Patients who are regarded as unsuitable by investigators for this clinical trial.
研究组 & 干预措施
Escitalopram
Escitalopram monotherapy (10-20 mg/day）
干预措施: Escitalopram (Drug)
Escitalopram + omega-3 PUFAs
Escitalopram (10-20 mg/day）combined with omega-3 PUFAs （EPA 900mg，DHA 300 mg）
干预措施: Escitalopram+omega-3 PUFAs (Drug)
Escitalopram + Aripiprazole
Escitalopram (10-20 mg/day）combined with Aripiprazole （2.5-10 mg/day)
干预措施: Escitalopram+Aripiprazole (Drug)
Escitalopram + omega-3 PUFAs + Aripiprazole
Escitalopram (10-20 mg/day）combined with omega-3 PUFAs （EPA 900mg，DHA 300 mg）and Aripiprazole （2.5-10 mg/day)
干预措施: Escitalopram+Aripiprazole+omega-3 PUFAs (Drug)
结局指标
主要结局
17-item Hamilton depression rating scale (HAMD-17) value
时间窗: Day 0 to Day 56
The value of 17-item Hamilton depression rating scale (HAMD-17) total score treatment compared to that at the baseline. The maximum score of HAMD-17 is 51 and the minimum is 0. Higher scores mean a worse outcome.
Anhedonia level-Dimensional Anhedonia Rating Scale (DARS)
时间窗: Day 0 to Day 56
The outcome is measured by Dimensional Anhedonia Rating Scale (DARS) total score. The maximum score of DARS total score is 68 and the minimum is 0. Higher scores mean a better outcome.
次要结局
- Anxiety symptoms(Day 0 to Day 14, Day 0 to Day 28, Day 0 to Day 56)
研究者
Si Tianmei
Professor
Peking University Sixth Hospital