A Positron Emission Topographic (PET) Study on Depression Patient With Electroacupuncture
Condition: Major Depressive Disorder; Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      This is a randomized, assessor-blind, placebo controlled study in major depressive disorder
      (MDD) patients. Subjects receiving antidepressant drug (FLX) would be assigned to receive
      either 18 sham / active DCEAS for in 6 weeks. Changes in the severity of depressive symptoms
      over time are measured using depression rating scales. Brain glucose metabolic levels are
      measured using PET at baseline and endpoint. The most intriguing and expected result might be
      that acupuncture treated-patients may display comparable or even better outcomes and the
      clinical improvements by acupuncture are correlated with the restoration of the activities in
      the related brain regions.
    

Detailed description: 
      Although the development of various classes of antidepressant drugs, represented by selective
      serotonin reuptake inhibitors (SSRI), has considerably improved the prognosis and the
      tolerability in the treatment of depressive disorders, the currently available antidepressant
      therapy is still incomplete, because there are about 40% of depressed individuals who cannot
      obtain full response and a large proportion of the patients experience recurrent episodes.

      Recently the principal investigator has completed a clinical trial to test whether dense
      cranial electroacupuncture stimulation (DCEAS) could enhance the antidepressant efficacy in
      the early phase of SSRI treatment (fluoxetine, FLX) of major depressive disorder (MDD). It
      was found that DCEAS is clinically safe and effective in augmenting the antidepressant
      efficacy in early SSRI treatment. As we hypothesize that this normalizing effect is
      associated with the modulation of various nervous functions associated with the
      pathophysiology of MDD, we design this neuroimaging (PET) DCEAS study to delineate the
      related mechanisms.

      The objective of this study are:

      1) To compare clinical improvements on depressive symptoms between DCEAS and FLX monotherapy
      in MDD subjects; (2) To determine the effects of DCEAS treatment on glucose metabolic levels
      in related brain regions in comparison with healthy controls and FLX-treated patients, using
      PET scanning; and (3) To correlate between clinical improvements and changes in PET-measured
      activities of related brain regions in a pool of the subjects treated with DCEAS and FLX.

      In this 6-week, assessor-blind, randomized, controlled study of DCEAS as additional treatment
      with the antidepressant drug FLX, a total of 82 patients with major depressive disorder (MDD)
      will be recruited. The patients will be randomly assigned to FLX (10-30 mg/day) combined with
      sham (n =41) or FLX with active DCEAS (n =41) (18 sessions, 3 sessions a week). Changes in
      the severity of depressive symptoms over time are measured using depressive instruments.
      Clinical response and remission rates are also calculated. Two sessions of PET scan will be
      conducted at baseline and endpoint. The study will be conducted at HKU School of Chinese
      Medicine, Queen Mary Hospital, and Kowloon Hospital, Hong Kong.
    

Intervention name(s): Fluoxetine; DCEAS (Hwato®/ Dongbang®); n-CEA (Strietberger®)
Intervention type(s): Drug; Procedure; Procedure
Intervention description(s): 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.; Six pairs of cranial acupoints are used: Baihui (Du-20) and Yintang (EX-HN3), left Sishencong (EX-HN1) and Toulinqi (GB15), right Sishencong (EX-HN1) and Toulinqi (GB15), bilateral Shuaigu (GB8), bilateral Taiyang (EX-HN5), and bilateral Touwei (ST8). All these acupoints are located on the forehead.
Disposable acupuncture needles (Hwato®/ Dongbang®, 0.30 mm in diameter and 25-40 mm in length) are inserted at a depth of 10-30 mm obliquely into acupoints, on which low- and high-frequency alternating electrical stimulation with continuous waves is conducted for 30 min. The intensity is adjusted to a level at which patients feel comfortable.; Streitberger's acupuncture needles will be applied on the same acupoints, with the same electrical stimulation parameters, except that the needles only adhere to the skin instead of insertion.
Other intervention name(s): Prozac; Sarafem; Fontex; Zactin; Lovan; Fluohexal; Auscap; Depreks; Floxet; Flunil; Fluox; Fluzac; Fluxen; Hwato®; Dongbang®; Strietberger®
Intervention MeSH terms: Fluoxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depressive Disorder; Depressive Symptoms; Depressive Syndrome; Emotional Depression