Acupuncture for Ischemic Post-stroke Depression
Primary Purpose
Post-stroke Depression
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
acupuncture
placebo
sham-acupoint acupuncture
Fluoxetine
Sponsored by
About this trial
This is an interventional treatment trial for Post-stroke Depression focused on measuring Post-Stroke Depression, Acupunture, Fluoxetine, RCT
Eligibility Criteria
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
Sites / Locations
- First Affiliated hospital of Tianjin University of TCM
- Tianjin Academy of Tradional Chinese Medicine Afflicated Hospital
- Beijing Hospital of Traditional Chinese Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
traditional acupuncture & placebo
sham-acupoint acupuncture & fluoxetine
Arm Description
Apply traditional acupuncture to treat the ischemic post-stroke depression according to TCM theory.
Fluoxetine was given at a dose of 20 mg/day. sham-acupoint will be penetrated for treat the ischemic post-stroke depression.
Outcomes
Primary Outcome Measures
17-item Hamilton Depression Scale( HAMD-17)
Depression symptoms are primarily measured using the 17-item Hamilton Depression Scale (HAMD-17)
Barthel Index (BI)
physical outcomes will be measured using Barthel Index (BI)
Clinical Global Impression (CGI)
Clinical Global Impression (CGI) would also be measured by clinician
Secondary Outcome Measures
Self-Rating Depression Scale(SDS)
Treatment Emergent Symptom Scale,(TESS )
Stroke diagnosis and evaluation criteria of Traditional Chinese Medicine(TCM)
Full Information
NCT ID
NCT02472613
First Posted
June 8, 2015
Last Updated
February 23, 2021
Sponsor
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Collaborators
State Administration of Traditional Chinese Medicine of the People's Republic of China, Tianjin Academy of Tradional Chinese Medicine Afflicated Hospital, Beijing Hospital of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02472613
Brief Title
Acupuncture for Ischemic Post-stroke Depression
Official Title
Comparison of Acupuncture and Fluoxetine for of Ischemic Post-stroke Depression:A Multicentre Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Collaborators
State Administration of Traditional Chinese Medicine of the People's Republic of China, Tianjin Academy of Tradional Chinese Medicine Afflicated Hospital, Beijing Hospital of Traditional Chinese Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-stroke Depression
Keywords
Post-Stroke Depression, Acupunture, Fluoxetine, RCT
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
208 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
traditional acupuncture & placebo
Arm Type
Experimental
Arm Description
Apply traditional acupuncture to treat the ischemic post-stroke depression according to TCM theory.
Arm Title
sham-acupoint acupuncture & fluoxetine
Arm Type
Active Comparator
Arm Description
Fluoxetine was given at a dose of 20 mg/day. sham-acupoint will be penetrated for treat the ischemic post-stroke depression.
Intervention Type
Device
Intervention Name(s)
acupuncture
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Placebo was given for 12 consecutive weeks.
Intervention Type
Device
Intervention Name(s)
sham-acupoint acupuncture
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Fluoxetine
Intervention Description
Fluoxetine was given at a dose of 20 mg/day for12 consecutive weeks.
Primary Outcome Measure Information:
Title
17-item Hamilton Depression Scale( HAMD-17)
Description
Depression symptoms are primarily measured using the 17-item Hamilton Depression Scale (HAMD-17)
Time Frame
12 weeks
Title
Barthel Index (BI)
Description
physical outcomes will be measured using Barthel Index (BI)
Time Frame
12 weeks
Title
Clinical Global Impression (CGI)
Description
Clinical Global Impression (CGI) would also be measured by clinician
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Self-Rating Depression Scale(SDS)
Time Frame
12 weeks
Title
Treatment Emergent Symptom Scale,(TESS )
Time Frame
12 weeks
Title
Stroke diagnosis and evaluation criteria of Traditional Chinese Medicine(TCM)
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Ratio of NAA/Cr,Cho/Cr,mI/Cr by Magnetic Resoance Spectroscopy(MRS)
Description
Compare the ratio of NAA/Cr,Cho/Cr,mI/Cr in brain bilateral dorsolateral prefrontal, anterior cingulate alter brain metabolism after treatment.
Time Frame
12 weeks
Title
Determination of the content change of cytokines IL-1β, IL-6, TNF-α, BDNF in plasma
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
First Affiliated hospital of Tianjin University of TCM
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300193
Country
China
Facility Name
Tianjin Academy of Tradional Chinese Medicine Afflicated Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Facility Name
Beijing Hospital of Traditional Chinese Medicine
City
Beijing
Country
China
12. IPD Sharing Statement
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Acupuncture for Ischemic Post-stroke Depression
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