AzTrials
AzTrials

Post-stroke DepressionNCT02472613

Acupuncture for Ischemic Post-stroke Depression

A study testing acupuncture and Fluoxetine in people with Post-stroke Depression, run by First Teaching Hospital of Tianjin University of Traditional Chinese Medicine at 3 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 45 to 80 years
Conditions the study is for
Post-stroke Depression
What is being tested?
acupuncture and Fluoxetine
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
208 participants
Where
3 sitesChina
Study dates
May 2016to 31 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • Beijing Hospital of Traditional Chinese Medicine

    Beijing

  • First Affiliated hospital of Tianjin University of TCM

    Tianjin, Tianjin Municipality, 300193

  • Tianjin Academy of Tradional Chinese Medicine Afflicated Hospital

    Tianjin, Tianjin Municipality

Other trials in China

About this study

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

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.

Read the 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.

Being tested
acupuncture, placebo, sham-acupoint acupuncture, Fluoxetine
Keywords
Post-Stroke Depression, Acupunture, Fluoxetine, RCT

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • placeboDrug

    Placebo was given for 12 consecutive weeks.

  • 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.

  • FluoxetineDrug

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

Study groups in NCT02472613
Study groupRoleWhat they receive
traditional acupuncture & placeboExperimentalApply traditional acupuncture to treat the ischemic post-stroke depression according to TCM theory.
Receives: Device: acupuncture; Drug: placebo
sham-acupoint acupuncture & fluoxetineActive comparatorFluoxetine was given at a dose of 20 mg/day. sham-acupoint will be penetrated for treat the ischemic post-stroke depression.
Receives: Device: sham-acupoint acupuncture; Drug: Fluoxetine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 17-item Hamilton Depression Scale( HAMD-17)

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

    Measured: 12 weeks

  2. Barthel Index (BI)

    physical outcomes will be measured using Barthel Index (BI)

    Measured: 12 weeks

  3. Clinical Global Impression (CGI)

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

    Measured: 12 weeks

Secondary outcomes (3)

  1. Self-Rating Depression Scale(SDS)

    Measured: 12 weeks

  2. Treatment Emergent Symptom Scale,(TESS )

    Measured: 12 weeks

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

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2015 (estimated)
  2. Study startMay 2016
  3. Primary completion31 Dec 2019
  4. Study completion31 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
208 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02472613
Sponsor's protocol ID
201407001-6B
Status last verified
Feb 2021
First submitted
8 Jun 2015
Last updated
24 Feb 2021
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing acupuncture and Fluoxetine in people with Post-stroke Depression, run by First Teaching Hospital of Tianjin University of Traditional Chinese Medicine at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

17-item Hamilton Depression Scale( HAMD-17) (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02472613.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in