Electroacupuncture Combined With Antidepressants for Post-stroke Depression
Condition: Depression; Stroke
MeSH terms: Stroke; Depression; Depressive Disorder
Study type: Interventional

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.
    

Intervention name(s): DCEAS (Hwato®/ Dongbang®); Body electro-acupuncture (Hwato®/ Dongbang®); n-CEA (Strietberger®); Fluoxetine
Intervention type(s): Procedure; Procedure; Procedure; Drug
Intervention description(s): 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.
Other intervention name(s): Hwato®; Dongbang®; Hwato®; Dongbang®; Strietberger®; Prozac; Sarafem; Fontex; Zactin; Lovan; Fluohexal; Auscap; Depreks; Floxet; Flunil; Fluox; Fluzac; Fluxen
Intervention MeSH terms: Fluoxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acupuncture; Post Stroke Depression; Depressive Disorder; Cardiovascular Accident; Stroke; Apoplexy; CVA