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Major Depressive Disorder | A Positron Emission Topographic (PET) Study on Depression Patient With Electroacupuncture

Major Depressive Disorder research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Major Depressive Disorder

Depression

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:FluoxetineSubjects 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.

Procedure:DCEAS (Hwato®/ Dongbang®)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.

Procedure:n-CEA (Strietberger®)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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

DCEASDense 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-CEANon-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.

Study Status

Completed

Start Date: June 2012

Completed Date: May 2015

Phase: N/A

Type: Interventional

Design:

Primary Outcome: HAMD-17

Secondary Outcome: PET scanning

Study sponsors, principal investigator, and references

Principal Investigator: Zhang-Jin Zhang, MMed, PhD

Lead Sponsor: The University of Hong Kong

Collaborator: Queen Mary Hospital, Hong Kong

More information:https://clinicaltrials.gov/show/NCT01479920

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