A Positron Emission Topographic (PET) Study on Depression Patient With Electroacupuncture
A Positron Emission Topographic (PET) Study on Depression Patient With Electroacupuncture
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.
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.
Inclusion Criteria:

 1. with righthandedness;

 2. have first-episode MDD diagnosed as the Diagnostic and Statistical Manual of Mental
 Disorders, 4th edition (DSM-IV); and

 3. HAMD-17 score is ≥ 20; and

 4. never had any psychoactive medications.

 Exclusion Criteria:

 1. unstable medical conditions;

 2. have suicidal ideas or attempts or aggressive behavior;

 3. previously experienced manic, hypomanic, or mixed episode;

 4. immediate family members have bipolar or psychotic disorders;

 5. treatment with investigational drugs in past 6 months;

 6. alcoholism or drug abuse in past 1 year; or

 7. have needle phobia.