Clinical trial NCT01174394: Electroacupuncture Combined With Antidepressants for Post-stroke Depression
Official title: A Randomized, Assessor-blind, Controlled Trial of Electroacupuncture Combined With Antidepressants in Treating Patients With Post-stroke Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Stroke
Keywords: Acupuncture
Post Stroke Depression
Depressive Disorder
Cardiovascular Accident
Stroke
Apoplexy
CVA
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Tung Wah Hospital
name: Kowloon Hospital, Hong Kong
First posted: 2010-08-03
Enrollment: 43
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: HAMD-17, GDS , BI and CGI
timeFrame: 28-day (course of treatment)
Secondary outcomes:
measure: Clinical response, latency and adverse events
timeFrame: 28-day (course of treatment)
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Tung Wah Hospital - Rehabilitation Unit, Department of Medicine
city: Kowloon
country: Hong Kong
facility: Kowloon Hospital - Department of Psychiatry
city: Kowloon
country: Hong Kong
facility: Kowloon Hospital - Department of Rehabilitation
Study officials:
affiliation: The University of Hong Kong
name: Zhang-Jin Zhang, MMed, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.