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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

About this trial

This is an interventional treatment trial for Post-stroke Depression focused on measuring Post-Stroke Depression, Acupunture, Fluoxetine, RCT

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

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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