Acupuncture for Ischemic Post-stroke Depression

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison of Acupuncture and Fluoxetine for of Ischemic Post-stroke Depression：A Multicentre Randomized Controlled Trial

Conditions
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Post-stroke Depression

Intervention / Treatment
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* Device: acupuncture
* Drug: placebo
* Device: sham-acupoint acupuncture
* Drug: Fluoxetine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: traditional acupuncture & placebo<br>Apply traditional acupuncture to treat the ischemic post-stroke depression according to TCM theory. | Device: acupuncture<br>* Patients will be treated at Renzhong（Du26）, Yintang（EX-HN3）、accupuncture Shangxing（DU23）penetrate to Baihui（DU20）,Sishencong（EX-HN1）; Neiguan（PC6）,Sibai（ST2）,Fengchi（GB20）and Sanyinjiao（SP6）in bilateral;Jianyu（LI15）,Quchi（LI11）,Shousanli（LI10）,Hegu（LI 4）, Fengshi (GB31),Xuehai（SP10） ,Zusanli（ST36）、Taichong（LR 3） of the hemiplegia side. There are another six groups of acupoints in bilateral. The acupuncturist will choose one group acupoints according to patients syndrome:Zhigou (SJ6),Qimen (LR14);Xingjian (LR2),Xiaxi(GB43);Fenglong (ST40),Lianquan(RN23);Tongli (HT5),Xinshu (BL15);Xinshu (BL15),Pishu(BL20);Shenshu (BL23),Taixi (KI3). The acupoints are inserted at the depth of 20-30mm except Renzhong（Du26）, Sibai（ST2）, Sishencong（EX-HN1）are inserted at the depth of 5-10mm. The needles will be left for 30 minutes and then removed. Acupuncture treatment will consist of three sessions per week for 12 consecutive weeks.<br>Drug: placebo<br>* Placebo was given for 12 consecutive weeks.<br>|
| Active Comparator: sham-acupoint acupuncture & fluoxetine<br>Fluoxetine was given at a dose of 20 mg/day. sham-acupoint will be penetrated for treat the ischemic post-stroke depression. | Device: sham-acupoint acupuncture<br>* Jianliao（SJ14）,Tianquan（PC2）,Xiabai (LU4),Xiaoluo (SJ12),Shouwuli (LI13),Sidu (SJ9),Huizong (SJ7),Wenliu (LI7),Zhouliao (LI12),Quze（PC3）,Kongzui（LI6）,Zhigou（SJ6）,Zhongzhu（SJ3）,Futu（ST32）,Jimen (SP11),Yinshi (ST33),Liangqiu（ST34）,Shangjuxu（ST37）,Xiajuxu（ST39）,Xiyangguan（GB33）,Ligou（LR5）,Pucan (BL61),Jinggu (BL64),Rangu (KI2),Ligou (LR5),Neiting （ST44） of the hemiplegia side. • The acupoints are inserted at the depth of 20-30mm,except Pucan (BL61),Jinggu (BL64),Rangu (KI2) ,Neiting （ST44）are inserted at the depth of 5-10mm. The needles will be left for 30 minutes and then removed. Acupuncture treatment will consist of three sessions per week for 12 consecutive weeks.<br>Drug: Fluoxetine<br>* Fluoxetine was given at a dose of 20 mg/day for12 consecutive weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 17-item Hamilton Depression Scale( HAMD-17) | Depression symptoms are primarily measured using the 17-item Hamilton Depression Scale (HAMD-17) | 12 weeks | 
| Barthel Index (BI) | physical outcomes will be measured using Barthel Index (BI) | 12 weeks | 
| Clinical Global Impression (CGI) | Clinical Global Impression (CGI) would also be measured by clinician | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RCT, Post-Stroke Depression, Acupunture, Fluoxetine