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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
43
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
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
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.
Time frame: 28-day (course of treatment)
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.
Time frame: 28-day (course of treatment)
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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.