Clinical Psychopharmacology Division Institute of Mental Health, Peking University
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- HRSD reduction ratio
研究概览
简要总结
The bipolar depression patients of 18-55 years old were recruited. At the time of enrollment, the demographic, symptomatic, neuropsychological, neurobiological and genetic data was collected. After the completion of the baseline assessment and examination, the patients were given lithium carbonate or lithium carbonate combined with SSRI antidepressant treatment. Clinical evaluation was performed at 2 and 8 weeks after treatment, including the therapeutic efficacy and adverse drug reactions, and monitoring of serum lithium concentration. The patients further receive the fMRI scans after treatment for 8 weeks. Through above work, this study aimed to provide some guidance for the use of antidepressants in patients with bipolar depression.
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
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 18-55 years old, bipolar depression
排除标准
- •other mental illness, serious somatic illnesses, MRI contradictions.
研究组 & 干预措施
lithium carbonate
recieve lithium carbonate
干预措施: Lithium Carbonate (Drug)
lithium carbonate combined with SSRI antidepressant treatment
recieve lithium carbonate combined with SSRI antidepressant treatment
干预措施: lithium carbonate combined with SSRI antidepressant treatment (Drug)
结局指标
主要结局
HRSD reduction ratio
时间窗: 8 weeks
HRSD reduction ratio
次要结局
未报告次要终点
研究者
Si Tianmei
Clinical Psychopharmacology Division Institute of Mental Health
Peking University