Acupuncture for Ischemic Post-stroke Depression

NCT ID: NCT02472613

Last Updated: 2021-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2019-12-31

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.

Conditions

Post-stroke Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

traditional acupuncture & placebo

Apply traditional acupuncture to treat the ischemic post-stroke depression according to TCM theory.

Group Type: EXPERIMENTAL

acupuncture

Intervention Type: 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

Intervention Type: DRUG

Placebo was given for 12 consecutive weeks.

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.

Group Type: ACTIVE_COMPARATOR

sham-acupoint acupuncture

Intervention Type: 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

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DEVICE

placebo

Placebo was given for 12 consecutive weeks.

Intervention Type: DRUG

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.

Intervention Type: DEVICE

Fluoxetine

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

State Administration of Traditional Chinese Medicine of the People's Republic of China

OTHER_GOV

Sponsor Role: collaborator

Tianjin Academy of Tradional Chinese Medicine Afflicated Hospital

UNKNOWN

Sponsor Role: collaborator

Beijing Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Prof Zhang Chunhong

State Administration of Traditional Chinese Medicine of the People's Republic of China

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

First Affiliated hospital of Tianjin University of TCM

Tianjin, Tianjin Municipality, China

Tianjin Academy of Tradional Chinese Medicine Afflicated Hospital

Tianjin, Tianjin Municipality, China

Beijing Hospital of Traditional Chinese Medicine

Beijing, , China

Countries

China

Other Identifiers

201407001-6B

Identifier Type: -

Identifier Source: org_study_id