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Electroacupuncture Combined With Antidepressants for Post-stroke Depression

This study has been completed.
Sponsor:
Collaborators:
Tung Wah Hospital
Kowloon Hospital, Hong Kong
Information provided by (Responsible Party):
Prof. Zhang Zhang-Jin, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01174394
First received: July 29, 2010
Last updated: April 30, 2013
Last verified: April 2013

July 29, 2010
April 30, 2013
May 2010
February 2013   (final data collection date for primary outcome measure)
HAMD-17, GDS , BI and CGI [ Time Frame: 28-day (course of treatment) ] [ Designated as safety issue: No ]
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.
HAMD-17, GDS , BI and CGI [ Time Frame: 28-day (course of treatment) ] [ Designated as safety issue: No ]
Depression symptoms are primarly measured using the 17-item Hamilton Self-Rating 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.
Complete list of historical versions of study NCT01174394 on ClinicalTrials.gov Archive Site
Clinical response, latency and adverse events [ Time Frame: 28-day (course of treatment) ] [ Designated as safety issue: Yes ]

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.

Clinical response, latency and adverse events [ Time Frame: 28-day (course of treatment) ] [ Designated as safety issue: Yes ]

The secondary efficacy measures include clinical response, defined as <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.

Not Provided
Not Provided
 
Electroacupuncture Combined With Antidepressants for Post-stroke Depression
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • Depression
  • Stroke
  • Procedure: DCEAS (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.
    Other Names:
    • Hwato®
    • Dongbang®
  • Procedure: Body electro-acupuncture (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.
    Other Names:
    • Hwato®
    • Dongbang®
  • Procedure: n-CEA (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
    Other Name: Strietberger®
  • Drug: Fluoxetine
    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.
    Other Names:
    • Prozac
    • Sarafem
    • Fontex
    • Zactin
    • Lovan
    • Fluohexal
    • Auscap
    • Depreks
    • Floxet
    • Flunil
    • Fluox
    • Fluzac
    • Fluxen
  • Experimental: DCEAS

    Body 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.

    Interventions:
    • Procedure: DCEAS (Hwato®/ Dongbang®)
    • Procedure: Body electro-acupuncture (Hwato®/ Dongbang®)
    • Drug: Fluoxetine
  • Placebo Comparator: n-CEA

    Body 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.

    Interventions:
    • Procedure: Body electro-acupuncture (Hwato®/ Dongbang®)
    • Procedure: n-CEA (Strietberger®)
    • Drug: Fluoxetine
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
February 2013
February 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Both
35 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Hong Kong
 
NCT01174394
UW 10-211
Yes
Prof. Zhang Zhang-Jin, The University of Hong Kong
The University of Hong Kong
  • Tung Wah Hospital
  • Kowloon Hospital, Hong Kong
Principal Investigator: Zhang-Jin Zhang, MMed, PhD The University of Hong Kong
The University of Hong Kong
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP