NCT02472613

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
208

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 16, 2015

Completed
11 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

February 24, 2021

Status Verified

February 1, 2021

Enrollment Period

3.7 years

First QC Date

June 8, 2015

Last Update Submit

February 23, 2021

Conditions

Post-stroke Depression

Keywords

Post-Stroke DepressionAcupuntureFluoxetineRCT

Outcome Measures

Primary Outcomes (3)

  • 17-item Hamilton Depression Scale( HAMD-17)

    Depression symptoms are primarily measured using the 17-item Hamilton Depression Scale (HAMD-17)

    12 weeks

  • Barthel Index (BI)

    physical outcomes will be measured using Barthel Index (BI)

    12 weeks

  • Clinical Global Impression (CGI)

    Clinical Global Impression (CGI) would also be measured by clinician

    12 weeks

Secondary Outcomes (3)

  • Self-Rating Depression Scale(SDS)

    12 weeks

  • Treatment Emergent Symptom Scale,(TESS )

    12 weeks

  • Stroke diagnosis and evaluation criteria of Traditional Chinese Medicine（TCM）

    12 weeks

Other Outcomes (2)

  • Ratio of NAA/Cr，Cho/Cr，mI/Cr by Magnetic Resoance Spectroscopy(MRS)

    12 weeks

  • Determination of the content change of cytokines IL-1β, IL-6, TNF-α, BDNF in plasma

    12 weeks

Study Arms (2)

traditional acupuncture & placebo

EXPERIMENTAL

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

Device: acupunctureDrug: placebo

sham-acupoint acupuncture & fluoxetine

ACTIVE COMPARATOR

Fluoxetine was given at a dose of 20 mg/day. sham-acupoint will be penetrated for treat the ischemic post-stroke depression.

Device: sham-acupoint acupunctureDrug: Fluoxetine

Interventions

acupunctureDEVICE

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.

traditional acupuncture & placebo
placeboDRUG

Placebo was given for 12 consecutive weeks.

traditional acupuncture & placebo
sham-acupoint acupunctureDEVICE

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.

sham-acupoint acupuncture & fluoxetine
FluoxetineDRUG

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

sham-acupoint acupuncture & fluoxetine

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

First Affiliated hospital of Tianjin University of TCM

Tianjin, Tianjin Municipality, 300193, China

Location

Tianjin Academy of Tradional Chinese Medicine Afflicated Hospital

Tianjin, Tianjin Municipality, China

Location

Beijing Hospital of Traditional Chinese Medicine

Beijing, China

Location

MeSH Terms

Interventions

Acupuncture TherapyFluoxetine

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPropylaminesAminesOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
State Administration of Traditional Chinese Medicine of the People's Republic of China

Study Record Dates

First Submitted

June 8, 2015

First Posted

June 16, 2015

Study Start

May 1, 2016

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

February 24, 2021

Record last verified: 2021-02

Locations

CN(3)