Comparison of Acupuncture and Fluoxetine for of Ischemic Post-stroke Depression：A Multicentre Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 208
- 试验地点
- 3
- 主要终点
- 17-item Hamilton Depression Scale( HAMD-17)
研究概览
简要总结
This is a multicentre, single Blind ,randomized controlled clinical trial in ischemic post-stroke depression patients.The participants will be allocated randomly in either of the two groups: verum acupuncture plus placebo medication group or sham acupuncture plus true medication group. On the hypothesis that acupuncture intervention could produce the same therapeutic effects as antidepressants. The investigators also hypothesized that acupuncture would be associated with minimal side effects.
详细描述
Aim: To observe the curative effect of acupuncture in the treatment of Ischemic Post-Stroke Depression． Design: A multicentre,open-label randomized controlled trial will be performed in Tianjin and Beijing . Two hundred and eight participants with Ischemic Post-Stroke Depression patients were randomly divided into two groups which were both given basic treatment of stroke. The acupuncture group was given Tiaoshenkaiqiao acupuncture therapy and placebo，while the control group was treated with fluoxetine tablets and sham acupoint acupuncture treatment. Evaluated the clinical efficacy of the two groups with Hamilton Depression Scale(HAMD), Barthel Index (BI),Treatment Emergent Symptom Scale,(TESS ),Clinical Global Impression Scale(CGI) respectively before treatment, the second weekend of treatment ,the fourth weekend of treatment, the eighth weekend of treatment, the twelfth weekend of treatment. And observed the adverse reaction of the two groups.
Each participants will receive 36 sessions of acupuncture in 12 weeks, with a duration of 30 minutes in a session. After all the treatments were accomplished, there will be one follow-ups in the 24th week.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •in accordance with diagnosis of ischemic stroke in International Classification of Diseases-10 163, （ICD-10 163）;
- •diagnosis of a major depressive episode according to the depression module of the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders-IV （DSM-IV）or Chinese Classification and Diagnostic Criteria of Mental Disorders-3(CCMD-3)
- •age of a subject is between 40 and 80 years old, male or female;
- •most recently experience an ischemic post-stroke depression and recent (<6 months);
- •conscious, examination cooperation, without aphasia and severe cognitive impairment;
- •capacity to provide written consent for both research assessment and treatment.
排除标准
- •participation in any clinical trial within the previous or taking antidepressant treatment 2 weeks prior to baseline;
- •presence of severe cognitive dysfunction, indicated the Mini-mental State Examination (MMSE) score of < 17
- •presence of severe aphasia;
- •had a history of psychiatric illness or depression
- •impaired hepatic , renal function., hematological systems and so on;
- •those who can not cooperate with treatment;
- •pregnant women or women in lactation
- •presence of another chronic disorder, including chronic alcoholism or durg abuse
研究组 & 干预措施
traditional acupuncture & placebo
Apply traditional acupuncture to treat the ischemic post-stroke depression according to TCM theory.
干预措施: acupuncture (Device)
traditional acupuncture & placebo
Apply traditional acupuncture to treat the ischemic post-stroke depression according to TCM theory.
干预措施: placebo (Drug)
sham-acupoint acupuncture & fluoxetine
Fluoxetine was given at a dose of 20 mg/day. sham-acupoint will be penetrated for treat the ischemic post-stroke depression.
干预措施: sham-acupoint acupuncture (Device)
sham-acupoint acupuncture & fluoxetine
Fluoxetine was given at a dose of 20 mg/day. sham-acupoint will be penetrated for treat the ischemic post-stroke depression.
干预措施: Fluoxetine (Drug)
结局指标
主要结局
17-item Hamilton Depression Scale( HAMD-17)
时间窗: 12 weeks
Depression symptoms are primarily measured using the 17-item Hamilton Depression Scale (HAMD-17)
Barthel Index (BI)
时间窗: 12 weeks
physical outcomes will be measured using Barthel Index (BI)
Clinical Global Impression (CGI)
时间窗: 12 weeks
Clinical Global Impression (CGI) would also be measured by clinician
次要结局
- Self-Rating Depression Scale(SDS)(12 weeks)
- Treatment Emergent Symptom Scale,(TESS )(12 weeks)
- Stroke diagnosis and evaluation criteria of Traditional Chinese Medicine（TCM）(12 weeks)
研究者
Prof Zhang Chunhong
State Administration of Traditional Chinese Medicine of the People's Republic of China
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine