Randomized Double Blinding Controlled Study on" Jia Wei Xiao Yao Jiaonang" Treating Mild to Moderate Major Depressive Disorder
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- HAMD scale
研究概览
简要总结
This is a randomized, double-blind multi centric clinic study. Both of therapist and patient are blind. There are 180 patients from 3 hospitals included, who meet DSM-IV criteria for major depressive disorder, the score of HAMD-item>20，<35；and meet the criteria for TCM syndrome of "Liver Qi stagnation and Transformation of Stagnant Qi into Fire". Patients are randomized to JWXY and sertraline treatment groups, receiving oral sertraline (start with 50 mg/day for one week then continue with 50 mg/day) plus placebo of JWXYJN; or oral JWXYJN plus placebo of sertraline daily for 2 months. The symptoms of depression and anxiety are measured with HAMD and HAMA tests at baseline and at 2，4，8 weeks; and LFT, BUN, Cr are assessed at baseline and end of program. Then data will be analyzed with SPSS software to determine the efficacy and safety of JWXYJN comparing to sertraline in the treatment of mild to moderate major depressive disorder.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 years or older.
- •A diagnosis of MDD, single episode or recurrent, according to DSM-IV
- •Meets DSM-IV criteria for Major Depressive Disorder.
- •factor score from the 24-item Hamilton Depression Rating Scale (HAM-D) >20,<35
- •Patients must be able to provide written informed consent
排除标准
- •Patients with a current (or within 6 months prior to the Screening Visit) Axis I disorder of Post Traumatic Stress Disorder, Eating Disorder, Obsessive Compulsive Disorder.
- •Patients with a history of schizophrenia, schizoaffective disorder or bipolar I or II disorder (with a history of hypomanic or manic episodes).
- •Patients who meet DSM-IV criteria for substance abuse (alcohol or drugs) within 3 months prior to Screening Visit or substance dependence within 6 months prior to the Screening Visit.
- •Patients who meet criteria for any of the following DSM-IV MDD Specifiers: [a] With Catatonic Features; [b] With Postpartum Onset; [c] With Seasonal Pattern [d] with Psychotic Features.
- •Patients who are receiving formal psychotherapy or have had psychotherapy within the 12 weeks prior to the Screening Visit.
研究组 & 干预措施
Chinese medicine
There are 90 patients with mild to moderate depress in JWXY group, who take the JWXY capsule, and placebo of Sertraline, for 2 months
干预措施: JWXYJN plus placebo of Sertraline (Drug)
westen medicine
There are 90 patients with mild to moderate depress in westen medicine group, who take Sertraline, and placebo of the JWXY capsule, for 2 months
干预措施: Sertraline plus placebo of JWXYJN (Drug)
结局指标
主要结局
HAMD scale
时间窗: 12 weeks
HAMD scale to access the depression level
次要结局
未报告次要终点
研究者
Su Rui
assistant researcher
China Academy of Chinese Medical Sciences