A Positron Emission Topographic (PET) Study on Depression Patient With Electroacupuncture
The Identification of Central Neural Network for Antidepressant Effects of Dense Cranial Electroacupuncture Stimulation - a Positron Emission Topographic (PET) Study
1 other identifier
interventional
36
2 countries
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable major-depressive-disorder
Started Jun 2012
Typical duration for not_applicable major-depressive-disorder
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 16, 2011
CompletedFirst Posted
Study publicly available on registry
November 28, 2011
CompletedStudy Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedDecember 7, 2015
December 1, 2015
2.9 years
November 16, 2011
December 4, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
HAMD-17
Depression symptoms is measured using the 17-item Hamilton Depression Scale. Assessments will be conducted at baseline and once weekly thereafter.
42-day (course of treatment)
SDS
Depression symptoms is measured using the Self-Rating Depression Scale (SDS). Assessments will be conducted at baseline and once weekly thereafter.
42-day (course of treatment)
Secondary Outcomes (5)
PET scanning
42-day (course of treatment)
Clinical response
42-day (course of treatment)
Remission
42-day (course of treatment)
Latency
42-day (course of treatment)
Adverse events
42-day (course of treatment)
Study Arms (2)
DCEAS
ACTIVE COMPARATORDense 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.
n-CEA
SHAM COMPARATORNon-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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- with righthandedness;
- have first-episode MDD diagnosed as the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV); and
- HAMD-17 score is ≥ 20; and
- never had any psychoactive medications.
You may not qualify if:
- unstable medical conditions;
- have suicidal ideas or attempts or aggressive behavior;
- previously experienced manic, hypomanic, or mixed episode;
- immediate family members have bipolar or psychotic disorders;
- treatment with investigational drugs in past 6 months;
- alcoholism or drug abuse in past 1 year; or
- have needle phobia.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The University of Hong Konglead
- Queen Mary Hospital, Hong Kongcollaborator
- Kowloon Hospital, Hong Kongcollaborator
- Southern Medical University, Chinacollaborator
Study Sites (4)
School of Traditional Chinese Medicine, Southern Medical University
Guangzhou, China
Department of Psychiatry, Queen Mary Hospital
Hong Kong, China
Department of Psychiatry, Kowloon Hospital
Kowloon, China
Department of Diagnostic Radiology, The University of Hong Kong
Hong Kong, Hong Kong
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhang-Jin Zhang, MMed, PhD
School of Chinese Medicine, The University of Hong Kong
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 16, 2011
First Posted
November 28, 2011
Study Start
June 1, 2012
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
December 7, 2015
Record last verified: 2015-12