A Positron Emission Topographic (PET) Study on Depression Patient With Electroacupuncture
Information source: The University of Hong Kong
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Major Depressive Disorder; Depression
Intervention: Fluoxetine (Drug); DCEAS (Hwato®/ Dongbang®) (Procedure); n-CEA (Strietberger®) (Procedure)
Phase: N/A
Status: Recruiting
Sponsored by: The University of Hong Kong Official(s) and/or principal investigator(s): Zhang-Jin Zhang, MMed, PhD, Principal Investigator, Affiliation: School of Chinese Medicine, The University of Hong Kong
Overall contact: Zhang-Jin Zhang, MMed, PhD, Phone: +85225890445, Email: zhangzj@hkucc.hku.hk
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.
Clinical Details
Official title: The Identification of Central Neural Network for Antidepressant Effects of Dense Cranial Electroacupuncture Stimulation - a Positron Emission Topographic (PET) Study
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: HAMD-17SDS
Secondary outcome: PET scanningClinical response Remission Latency Adverse events
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.
Eligibility
Minimum age: 22 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Zhang-Jin Zhang, MMed, PhD, Phone: +85225890445, Email: zhangzj@hkucc.hku.hk
School of Traditional Chinese Medicine, Southern Medical University, Guangzhou, China; Not yet recruiting Yong HUANG, MMed, PhD, Phone: +86-20-61648254, Email: nanfanglihuang@163.com Yong HUANG, MMed, PhD, Principal Investigator
Department of Psychiatry, Queen Mary Hospital, Hong Kong, China; Recruiting Ka-Fai CHUNG, MBBS, Phone: +85222554486, Email: kfchung@hkucc.hku.hk Ka-Fai CHUNG, MBBS, Principal Investigator
Department of Psychiatry, Kowloon Hospital, Kowloon, China; Recruiting Roger NG, MBChB, MSc, Phone: +85231296432, Email: ngmk@ha.org.hk Roger NG, MBChB, MSc, Principal Investigator
Department of Diagnostic Radiology, The University of Hong Kong, Hong Kong, Hong Kong; Not yet recruiting Chun-Sing WONG, MBChB, Phone: +85222553307, Email: drcswong@hku.hk Chun-Sing WONG, MBChB, Principal Investigator
Additional Information
HKU-SCM PET-RCT
Starting date: June 2012
Last updated: December 2, 2014
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