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DepressionNCT01174394

Electroacupuncture Combined With Antidepressants for Post-stroke Depression

A study testing DCEAS (Hwato®/ Dongbang®), Body electro-acupuncture (Hwato®/ Dongbang®) and n-CEA (Strietberger®) in people with Depression and Stroke, run by The University of Hong Kong at 3 sites in Hong Kong.

Completed

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

Official record
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Trial summary

This is a randomized, assessor-blind, placebo controlled study in post stroke depression patients. Subjects receiving antidepressant drug would be assigned to either active or placebo scalp electro-acupuncture treatment, on the hypothesis that acupuncture intervention combined with antidepressants could produce… Read more about this study

Who is it for?
Ages 35 to 80 years
Conditions the study is for
Depression, Stroke
What is being tested?
DCEAS (Hwato®/ Dongbang®), Body electro-acupuncture (Hwato®/ Dongbang®) and n-CEA (Strietberger®)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
43 participants
Where
3 sitesHong Kong
Study dates
May 2010to Feb 2013
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 35 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • most recently experience an ischemic or hemorrhagic stroke, documented by cerebral computed topographic scanning or magnetic resonance imaging
  • develop significant depression, with a HAMD-17 score of 16 or greater

Who cannot join

  • presence of severe aphasia, especially fluent aphasia
  • presence of severe cognitive dysfunction, indicated the Mini-mental State Examination (MMSE) score of < 18
  • had a history of psychiatric illness other than depression
  • presence of another chronic disorder, including severe Parkinson's disease, cardiac disease, cancers, epilepsy, or chronic alcoholism
  • impaired hepatic or renal function
  • have bleeding tendency

Trial locations and contacts

3 sites in 1 country.

Hong Kong3 sites

  • Tung Wah Hospital - Rehabilitation Unit, Department of Medicine

    Hong Kong

  • Kowloon Hospital - Department of Psychiatry

    Kowloon

  • Kowloon Hospital - Department of Rehabilitation

    Kowloon

Other trials in Hong Kong

About this study

Official title: A Randomized, Assessor-blind, Controlled Trial of Electroacupuncture Combined With Antidepressants in Treating Patients With Post-stroke Depression

This is a randomized, assessor-blind, placebo controlled study in post stroke depression patients. Subjects receiving antidepressant drug would be assigned to either active or placebo scalp electro-acupuncture treatment, on the hypothesis that acupuncture intervention combined with antidepressants could produce greater therapeutic effects than antidepressants alone.

Read the detailed description

Mood depression is a common and serious consequence of stroke. A large proportion of stroke patients develop post-stroke depression (PSD), either in the early or late stages after stroke. Although antidepressant agents, represented by selective serotonin reuptake inhibitors (SSRIs), are recommended as first-line drugs in pharmaco-therapy of PSD, its effectiveness is limited and the clinical use is largely hampered due to broad side effects, especially on cardiovascular system. In addition, since stroke patients are often medicated with various classes of drugs, the addition of antidepressant agents may increase risk of drug-drug interactions, resulting in unexpected and unpredictable adverse events.

The objective of this proposed study is to determine whether electro-acupuncture (EA) combined with antidepressants could produce significantly greater improvement on depressive symptoms in patients with PSD compared to antidepressants alone.

In this 4-week, assessor-blind, randomized, controlled study of electro-acupuncture (EA) as additional treatment with the antidepressant drug called fluoxetine (FLX), a total of 60 patients with post-stroke depression (PSD) will be recruited. The patients will be randomly assigned to FLX (10-30 mg/day) combined with active cranial and body acupuncture (n =30) or FLX with placebo cranial and active body acupuncture (n =30) (12 sessions, 3 sessions a week). Changes in the severity of depressive symptoms over time are measured using depressive scale instruments. Clinical response and remission rates are also calculated. The study will be conducted at HKU School of Chinese Medicine, Tung Wah Hospital, and Kowloon Hospital, Hong Kong.

Conditions
Depression, Stroke
Being tested
DCEAS (Hwato®/ Dongbang®), Body electro-acupuncture (Hwato®/ Dongbang®), n-CEA (Strietberger®), Fluoxetine
Keywords
Acupuncture, Post Stroke Depression, Depressive Disorder, Cardiovascular Accident, Stroke, Apoplexy, CVA
Medical subject headings
Depression, Stroke, Depressive Disorder

What participants receive

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

  • DCEAS (Hwato®/ Dongbang®)Procedure or surgery

    Also called Hwato®, Dongbang®

    Upon insertion of acupuncture needles, dense cranial electro-acupuncture stimulation (DCEAS), is directly delivered on a density of cranial acupoints (in general 6-8 pairs) located on the frontal, parietal, and temporal scalp areas.

  • Body electro-acupuncture (Hwato®/ Dongbang®)Procedure or surgery

    Also called Hwato®, Dongbang®

    Both study arms received body electroacupuncture on both sides of ipsilateral limb pairs: Hegu (LI4) and Quchi (LI11) , Zusanli (ST36) and Taichong (LR3). Electrical stimulation as DCEAS is applied.

  • n-CEA (Strietberger®)Procedure or surgery

    Also called Strietberger®

    Streitberger's non-invasive acupuncture needles were applied to serve as sham control at the same cranial acupoints and the same stimulation modality, except that the needles only adhere to the skin instead of insertion

  • FluoxetineDrug

    Also called Prozac, Sarafem, Fontex, Zactin

    Subjects of both study arms received orally administered SSRIs for 4 weeks in an open manner. For those who were currently under antidepressant treatment, they would continue the existing treatment regimens. For those who were not medicated at the time of trial, fluoxetine (FLX) was given at an initiate dose of 10 mg/day and escalated to an optimal dose within one week, based on individual response, but the maximum dose was set at 40 mg/day.

Study groups in NCT01174394
Study groupRoleWhat they receive
DCEASExperimentalBody electroacupuncture plus dense cranial electroacupuncture stimulation (DCEAS) For those who were currently under antidepressant treatment, they would continue the existing treatment regimens. For those who were not medicated at the time of trial, fluoxetine (FLX) was given at an initiate dose of 10 mg/day and escalated to an optimal dose within one week, based on individual response, but the maximum dose was set at 40 mg/day.
Receives: Procedure: DCEAS (Hwato®/ Dongbang®); Procedure: Body electro-acupuncture (Hwato®/ Dongbang®); Drug: Fluoxetine
n-CEAPlacebo comparatorBody electroacupuncture plus non-invasive cranial electroacupuncture (n-CEA) For those who were currently under antidepressant treatment, they would continue the existing treatment regimens. For those who were not medicated at the time of trial, fluoxetine (FLX) was given at an initiate dose of 10 mg/day and escalated to an optimal dose within one week, based on individual response, but the maximum dose was set at 40 mg/day.
Receives: Procedure: Body electro-acupuncture (Hwato®/ Dongbang®); Procedure: n-CEA (Strietberger®); Drug: Fluoxetine

What is being measured

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

  1. HAMD-17, GDS , BI and CGI

    Depression symptoms are primarily measured using the 17-item Hamilton Depression Scale (HAMD-17) and Geriatric Depression Scale (GDS); physical outcomes will be measured using Barthel Index (BI); Clinical Global Impression (CGI) would also be measured by clinician. The measurements are carried out at the baseline, first, second and fourth week of treatment course.

    Measured: 28-day (course of treatment)

Secondary outcomes (1)

  1. Clinical response, latency and adverse events

    The secondary efficacy measures include clinical response, defined as greater than or equal to 50% reduction at endpoint from baseline on HAMD-17; remission, defined as 7 points or less on HAMD-17 score; and the latency of the clinical response. The measurements are carried out at the baseline, first, second and fourth week of treatment course.

    Adverse events are assessed using the Treatment Emergent Symptom Scale (TESS) when applicable.

    Measured: 28-day (course of treatment)

Timeline

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

  1. First posted3 Aug 2010 (estimated)
  2. Study startMay 2010
  3. Primary completionFeb 2013
  4. Study completionFeb 2013

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
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01174394
Sponsor's protocol ID
UW 10-211
Status last verified
Apr 2013
First submitted
29 Jul 2010
Last updated
1 May 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Man SC, Hung BH, Ng RM, Yu XC, Cheung H, Fung MP, Li LS, Leung KP, Leung KP, Tsang KW, Ziea E, Wong VT, Zhang ZJ. A pilot controlled trial of a combination of dense cranial electroacupuncture stimulation and body acupuncture for post-stroke depression. BMC Complement Altern Med. 2014 Jul 19;14:255. doi: 10.1186/1472-6882-14-255.

    PubMed 25038733

Questions about this trial

What is this clinical trial studying?

A study testing DCEAS (Hwato®/ Dongbang®), Body electro-acupuncture (Hwato®/ Dongbang®) and n-CEA (Strietberger®) in people with Depression and Stroke, run by The University of Hong Kong at 3 sites in Hong Kong.

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 2 inclusion and 6 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 1 May 2013. 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 Hong Kong. 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. Some participants in this study may receive a placebo. 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?

HAMD-17, GDS , BI and CGI (time frame: 28-day (course of treatment)). 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 NCT01174394, which also lists 1 linked publication.

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 1 May 2013.

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