- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02472613
Acupuncture for Ischemic Post-stroke Depression
Comparison of Acupuncture and Fluoxetine for of Ischemic Post-stroke Depression:A Multicentre Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Beijing, China
- Beijing Hospital of Traditional Chinese Medicine
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Tianjin
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Tianjin, Tianjin, China, 300193
- First Affiliated hospital of Tianjin University of TCM
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Tianjin, Tianjin, China
- Tianjin Academy of Tradional Chinese Medicine Afflicated Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: traditional acupuncture & placebo
Apply traditional acupuncture to treat the ischemic post-stroke depression according to TCM theory.
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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.
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Active Comparator: sham-acupoint acupuncture & fluoxetine
Fluoxetine was given at a dose of 20 mg/day.
sham-acupoint will be penetrated for treat the ischemic post-stroke depression.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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17-item Hamilton Depression Scale( HAMD-17)
Time Frame: 12 weeks
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Depression symptoms are primarily measured using the 17-item Hamilton Depression Scale (HAMD-17)
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12 weeks
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Barthel Index (BI)
Time Frame: 12 weeks
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physical outcomes will be measured using Barthel Index (BI)
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12 weeks
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Clinical Global Impression (CGI)
Time Frame: 12 weeks
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Clinical Global Impression (CGI) would also be measured by clinician
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Self-Rating Depression Scale(SDS)
Time Frame: 12 weeks
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12 weeks
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Treatment Emergent Symptom Scale,(TESS )
Time Frame: 12 weeks
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12 weeks
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Stroke diagnosis and evaluation criteria of Traditional Chinese Medicine(TCM)
Time Frame: 12 weeks
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12 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Ratio of NAA/Cr,Cho/Cr,mI/Cr by Magnetic Resoance Spectroscopy(MRS)
Time Frame: 12 weeks
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Compare the ratio of NAA/Cr,Cho/Cr,mI/Cr in brain bilateral dorsolateral prefrontal, anterior cingulate alter brain metabolism after treatment.
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12 weeks
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Determination of the content change of cytokines IL-1β, IL-6, TNF-α, BDNF in plasma
Time Frame: 12 weeks
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12 weeks
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Mood Disorders
- Stroke
- Depression
- Depressive Disorder
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Cytochrome P-450 Enzyme Inhibitors
- Antidepressive Agents, Second-Generation
- Cytochrome P-450 CYP2D6 Inhibitors
- Fluoxetine
Other Study ID Numbers
- 201407001-6B
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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