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
  Purpose

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.


Condition Intervention
Depression
Stroke
Procedure: DCEAS (Hwato®/ Dongbang®)
Procedure: Body electro-acupuncture (Hwato®/ Dongbang®)
Procedure: n-CEA (Strietberger®)
Drug: Fluoxetine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Assessor-blind, Controlled Trial of Electroacupuncture Combined With Antidepressants in Treating Patients With Post-stroke Depression

Resource links provided by NLM:


Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.



Enrollment: 43
Study Start Date: May 2010
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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®
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
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.

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

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.

  Eligibility

Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01174394

Locations
Hong Kong
Tung Wah Hospital - Rehabilitation Unit, Department of Medicine
Hong Kong, Hong Kong
Kowloon Hospital - Department of Psychiatry
Kowloon, Hong Kong
Kowloon Hospital - Department of Rehabilitation
Kowloon, Hong Kong
Sponsors and Collaborators
The University of Hong Kong
Tung Wah Hospital
Kowloon Hospital, Hong Kong
Investigators
Principal Investigator: Zhang-Jin Zhang, MMed, PhD The University of Hong Kong
  More Information

Additional Information:
No publications provided

Responsible Party: Prof. Zhang Zhang-Jin, Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01174394     History of Changes
Other Study ID Numbers: UW 10-211
Study First Received: July 29, 2010
Last Updated: April 30, 2013
Health Authority: Hong Kong: Department of Health

Keywords provided by The University of Hong Kong:
Acupuncture
Post Stroke Depression
Depressive Disorder
Cardiovascular Accident
Stroke
Apoplexy
CVA

Additional relevant MeSH terms:
Depression
Depressive Disorder
Stroke
Cerebral Infarction
Behavioral Symptoms
Mood Disorders
Mental Disorders
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Antidepressive Agents
Fluoxetine
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation

ClinicalTrials.gov processed this record on July 22, 2014