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NCT Number: NCT02472613

Acupuncture for Ischemic Post-stroke Depression

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.

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Key information

Conditions

Post-stroke Depression

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First Affiliated hospital of Tianjin University of TCM, Tianjin, Tianjin Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

acupuncture

Device

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

Drug

Placebo was given for 12 consecutive weeks.

sham-acupoint acupuncture

Device

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

Drug

Fluoxetine was given at a dose of 20 mg/day for12 consecutive weeks.

Primary outcomes

  1. 17-item Hamilton Depression Scale( HAMD-17)

    Time frame: 12 weeks

    Depression symptoms are primarily measured using the 17-item Hamilton Depression Scale (HAMD-17)

  2. Barthel Index (BI)

    Time frame: 12 weeks

    physical outcomes will be measured using Barthel Index (BI)

  3. Clinical Global Impression (CGI)

    Time frame: 12 weeks

    Clinical Global Impression (CGI) would also be measured by clinician

Secondary outcomes

  1. Self-Rating Depression Scale(SDS)

    Time frame: 12 weeks

  2. Treatment Emergent Symptom Scale,(TESS )

    Time frame: 12 weeks

  3. Stroke diagnosis and evaluation criteria of Traditional Chinese Medicine（TCM）

    Time frame: 12 weeks

Other outcomes

  1. Ratio of NAA/Cr，Cho/Cr，mI/Cr by Magnetic Resoance Spectroscopy(MRS)

    Time frame: 12 weeks

    Compare the ratio of NAA/Cr，Cho/Cr，mI/Cr in brain bilateral dorsolateral prefrontal, anterior cingulate alter brain metabolism after treatment.

  2. Determination of the content change of cytokines IL-1β, IL-6, TNF-α, BDNF in plasma

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Other

Collaborators

  • Beijing Hospital of Traditional Chinese Medicine
  • State Administration of Traditional Chinese Medicine of the People's Republic of China
  • Tianjin Academy of Tradional Chinese Medicine Afflicated Hospital

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jun 16, 2015
Registry last updated
Feb 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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