A Positron Emission Topographic (PET) Study on Depression Patient With Electroacupuncture

• HAMD-17 [ Time Frame: 42-day (course of treatment) ] [ Designated as safety issue: No ]
  Depression symptoms is measured using the 17-item Hamilton Depression Scale. Assessments will be conducted at baseline and once weekly thereafter.
  
  
• SDS [ Time Frame: 42-day (course of treatment) ] [ Designated as safety issue: No ]
  Depression symptoms is measured using the Self-Rating Depression Scale (SDS). Assessments will be conducted at baseline and once weekly thereafter.
  
  

• PET scanning [ Time Frame: 42-day (course of treatment) ] [ Designated as safety issue: Yes ]
  The secondary outcome measure of high interest is the results of PET scanning. Two sessions of PET scan will be conducted at baseline and endpoint for enrolled subjects. An additional group of age- and gender-matched healthy subjects will be invited for one-session PET scan.
  
  
• Clinical response [ Time Frame: 42-day (course of treatment) ] [ Designated as safety issue: No ]
  Clinical response, defined as greater than or equal to 50% reduction at endpoint from baseline on HAMD-17, is measured at the baseline and once weekly thereafter.
  
  
• Remission [ Time Frame: 42-day (course of treatment) ] [ Designated as safety issue: No ]
  Remission, defined as 7 points or less on HAMD-17 score, is measured at the baseline and once weekly thereafter.
  
  
• Latency [ Time Frame: 42-day (course of treatment) ] [ Designated as safety issue: No ]
  The latency of the clinical response.
  
  
• Adverse events [ Time Frame: 42-day (course of treatment) ] [ Designated as safety issue: Yes ]
  Adverse events are assessed using the Treatment Emergent Symptom Scale (TESS) when applicable.
  
  

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.