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
1 other identifier
interventional
43
1 country
3
Brief 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 greater therapeutic effects than antidepressants alone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable depression
Started May 2010
Typical duration for not_applicable depression
3 active sites
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
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 29, 2010
CompletedFirst Posted
Study publicly available on registry
August 3, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedMay 1, 2013
April 1, 2013
2.8 years
July 29, 2010
April 30, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
28-day (course of treatment)
Secondary Outcomes (1)
Clinical response, latency and adverse events
28-day (course of treatment)
Study Arms (2)
DCEAS
EXPERIMENTALBody 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.
n-CEA
PLACEBO 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.
Interventions
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.
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.
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
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The University of Hong Konglead
- Tung Wah Hospitalcollaborator
- Kowloon Hospital, Hong Kongcollaborator
Study Sites (3)
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
Related Publications (1)
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.
PMID: 25038733DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhang-Jin Zhang, MMed, PhD
The University of Hong Kong
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
- Professor
Study Record Dates
First Submitted
July 29, 2010
First Posted
August 3, 2010
Study Start
May 1, 2010
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
May 1, 2013
Record last verified: 2013-04