Electroacupuncture Combined With Antidepressants for Post-stroke Depression

The University of Hong Kong (HKU)

Status: Completed

Conditions: Stroke; Depression

Treatments: Procedure: DCEAS (Hwato®/ Dongbang®); Drug: Fluoxetine; Procedure: Body electro-acupuncture (Hwato®/ Dongbang®); Procedure: n-CEA (Strietberger®)

Study type: Interventional

Funder types: Other

Identifiers

NCT01174394

UW 10-211

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 35 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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43 participants in 2 patient groups, including a placebo group

DCEAS

Experimental group

Description:

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.

Treatment:

Procedure: Body electro-acupuncture (Hwato®/ Dongbang®)

Drug: Fluoxetine

Procedure: DCEAS (Hwato®/ Dongbang®)

n-CEA

Placebo Comparator group

Description:

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.

Treatment:

Procedure: n-CEA (Strietberger®)

Procedure: Body electro-acupuncture (Hwato®/ Dongbang®)

Drug: Fluoxetine