Electroacupuncture Combined With Antidepressants for Post-stroke Depression

Completed

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Fluoxetine (Prozac®)Drug
    Other Names: Patients receiving fluoxetine
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Electro-acupuncture
    ARM 2: Kind: Experimental
    Label: Placebo acupuncture
    ARM 3: Kind: Experimental
    Label: DCEAS
    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.
    ARM 4: Kind: Experimental
    Label: n-CEA
    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.
  • Active scalp electro-acupuncture (Hwato®/ Dongbang®) Procedure
    Other Names: Hwato®; Dongbang®
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Electro-acupuncture
  • Active body electro-acupuncture (Hwato®/ Dongbang®) Procedure
    Other Names: Hwato®; Dongbang®
    Intervention Desc: Upon insertion of acupuncture needles on acupoints on the limbs, electrical stimulation as DCEAS is applied.
    ARM 1: Kind: Experimental
    Label: Electro-acupuncture
    ARM 2: Kind: Experimental
    Label: Placebo acupuncture
  • Placebo scalp electro-acupuncture (Strietberger®) Procedure
    Other Names: Strietberger®
    Intervention Desc: Streitberger's non-invasive acupuncture needles will be applied to serve as placebo control at the same cranial acupoints and the same stimulation modality, except that the needles only adhere to the skin instead of insertion.
    ARM 1: Kind: Experimental
    Label: Placebo acupuncture
  • DCEAS (Hwato®/ Dongbang®) Procedure
    Other Names: Hwato®; Dongbang®
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: DCEAS
    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.
  • Body electro-acupuncture (Hwato®/ Dongbang®) Procedure
    Other Names: Hwato®; Dongbang®
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: DCEAS
    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.
    ARM 2: Kind: Experimental
    Label: n-CEA
    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.
  • N-CEA (Strietberger®) Procedure
    Other Names: Strietberger®
    Intervention Desc: 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
    ARM 1: Kind: Experimental
    Label: n-CEA
    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.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary HAMD-17, GDS , BI and CGI 28-day (course of treatment) No
Secondary Clinical response, latency and adverse events 28-day (course of treatment) Yes

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