Acupuncture for Ischemic Post-stroke Depression

Post-stroke Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02472613
• Other study ID #: 201407001-6B
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2021
• Source: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Post-stroke Depression
• Stroke

Intervention

Device:
• acupuncture
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.

Drug:
• placebo
Placebo was given for 12 consecutive weeks.

Device:
• sham-acupoint acupuncture
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.

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

Locations

Country	Name	City	State
China	Beijing Hospital of Traditional Chinese Medicine	Beijing
China	First Affiliated hospital of Tianjin University of TCM	Tianjin	Tianjin
China	Tianjin Academy of Tradional Chinese Medicine Afflicated Hospital	Tianjin	Tianjin

Sponsors (4)

Lead Sponsor	Collaborator
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine	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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Ratio of NAA/Cr,Cho/Cr,mI/Cr by Magnetic Resoance Spectroscopy(MRS)	Compare the ratio of NAA/Cr,Cho/Cr,mI/Cr in brain bilateral dorsolateral prefrontal, anterior cingulate alter brain metabolism after treatment.	12 weeks
Other	Determination of the content change of cytokines IL-1ß, IL-6, TNF-a, BDNF in plasma		12 weeks
Primary	17-item Hamilton Depression Scale( HAMD-17)	Depression symptoms are primarily measured using the 17-item Hamilton Depression Scale (HAMD-17)	12 weeks
Primary	Barthel Index (BI)	physical outcomes will be measured using Barthel Index (BI)	12 weeks
Primary	Clinical Global Impression (CGI)	Clinical Global Impression (CGI) would also be measured by clinician	12 weeks
Secondary	Self-Rating Depression Scale(SDS)		12 weeks
Secondary	Treatment Emergent Symptom Scale,(TESS )		12 weeks
Secondary	Stroke diagnosis and evaluation criteria of Traditional Chinese Medicine(TCM)		12 weeks