Acupuncture for Ischemic Post-stroke Depression

Recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Fluoxetine (Prozac®)Drug
    Intervention Desc: Fluoxetine was given at a dose of 20 mg/day for12 consecutive weeks.
    ARM 1: Kind: Experimental
    Label: sham-acupoint acupuncture & fluoxetine
    Description: Fluoxetine was given at a dose of 20 mg/day. sham-acupoint will be penetrated for treat the ischemic post-stroke depression.
  • Acupuncture Device
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: traditional acupuncture & placebo
    Description: Apply traditional acupuncture to treat the ischemic post-stroke depression according to TCM theory.
  • Placebo Drug
    Intervention Desc: Placebo was given for 12 consecutive weeks.
    ARM 1: Kind: Experimental
    Label: traditional acupuncture & placebo
    Description: Apply traditional acupuncture to treat the ischemic post-stroke depression according to TCM theory.
  • Sham-acupoint acupuncture Device
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: sham-acupoint acupuncture & fluoxetine
    Description: Fluoxetine was given at a dose of 20 mg/day. sham-acupoint will be penetrated for treat the ischemic post-stroke depression.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Subject)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary 17-item Hamilton Depression Scale( HAMD-17) 12 weeks No
Primary Barthel Index (BI) 12 weeks No
Primary Clinical Global Impression (CGI) 12 weeks Yes
Secondary Self-Rating Depression Scale(SDS) 12 weeks No
Secondary Treatment Emergent Symptom Scale,(TESS ) 12 weeks Yes
Secondary Stroke diagnosis and evaluation criteria of Traditional Chinese Medicine(TCM) 12 weeks No

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