Acupuncture for Ischemic Post-stroke Depression
Condition: Post-stroke Depression
MeSH terms: Stroke; Depression; Depressive Disorder
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): acupuncture; placebo; sham-acupoint acupuncture; Fluoxetine
Intervention type(s): Device; Drug; Device; Drug
Intervention description(s): 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.; Placebo was given for 12 consecutive weeks.; 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.; Fluoxetine was given at a dose of 20 mg/day for12 consecutive weeks.
Intervention MeSH terms: Fluoxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Post-Stroke Depression; Acupunture; Fluoxetine; RCT