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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by The University of Hong Kong
Sponsor:
Collaborators:
Queen Mary Hospital, Hong Kong
Kowloon Hospital, Hong Kong
Southern Medical University, China
Information provided by (Responsible Party):
Prof. Zhang Zhang-Jin, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01479920
First received: November 16, 2011
Last updated: April 30, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Major Depressive Disorder
Depression
Drug: Fluoxetine
Procedure: DCEAS (Hwato®/ Dongbang®)
Procedure: n-CEA (Strietberger®)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Identification of Central Neural Network for Antidepressant Effects of Dense Cranial Electroacupuncture Stimulation - a Positron Emission Topographic (PET) Study

Resource links provided by NLM:


Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 82
Study Start Date: June 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: DCEAS

Dense 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.

Drug: Fluoxetine
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.
Other Names:
  • Prozac
  • Sarafem
  • Fontex
  • Zactin
  • Lovan
  • Fluohexal
  • Auscap
  • Depreks
  • Floxet
  • Flunil
  • Fluox
  • Fluzac
  • Fluxen
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.

Other Names:
  • Hwato®
  • Dongbang®
Sham Comparator: n-CEA

Non-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.

Drug: Fluoxetine
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.
Other Names:
  • Prozac
  • Sarafem
  • Fontex
  • Zactin
  • Lovan
  • Fluohexal
  • Auscap
  • Depreks
  • Floxet
  • Flunil
  • Fluox
  • Fluzac
  • Fluxen
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.
Other Name: Strietberger®

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

Ages Eligible for Study:   22 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01479920

Contacts
Contact: Zhang-Jin Zhang, MMed, PhD +85225890445 zhangzj@hkucc.hku.hk
Contact: Sui-Cheung Man, BCM, BSc +85225890466 marksman@hku.hk

Locations
China
School of Traditional Chinese Medicine, Southern Medical University Not yet recruiting
Guangzhou, China
Contact: Yong HUANG, MMed, PhD    +86-20-61648254    nanfanglihuang@163.com   
Principal Investigator: Yong HUANG, MMed, PhD         
Department of Psychiatry, Queen Mary Hospital Recruiting
Hong Kong, China
Contact: Ka-Fai CHUNG, MBBS    +85222554486    kfchung@hkucc.hku.hk   
Principal Investigator: Ka-Fai CHUNG, MBBS         
Department of Psychiatry, Kowloon Hospital Recruiting
Kowloon, China
Contact: Roger NG, MBChB, MSc    +85231296432    ngmk@ha.org.hk   
Principal Investigator: Roger NG, MBChB, MSc         
Hong Kong
Department of Diagnostic Radiology, The University of Hong Kong Not yet recruiting
Hong Kong, Hong Kong
Contact: Chun-Sing WONG, MBChB    +85222553307    drcswong@hku.hk   
Principal Investigator: Chun-Sing WONG, MBChB         
Sponsors and Collaborators
The University of Hong Kong
Queen Mary Hospital, Hong Kong
Kowloon Hospital, Hong Kong
Southern Medical University, China
Investigators
Principal Investigator: Zhang-Jin Zhang, MMed, PhD School of Chinese Medicine, The University of Hong Kong
  More Information

Additional Information:
No publications provided

Responsible Party: Prof. Zhang Zhang-Jin, Associate Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01479920     History of Changes
Other Study ID Numbers: UW 09-091
Study First Received: November 16, 2011
Last Updated: April 30, 2013
Health Authority: Hong Kong: Department of Health

Keywords provided by The University of Hong Kong:
Depressive Disorder
Depressive Symptoms
Depressive Syndrome
Emotional Depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Fluoxetine
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation

ClinicalTrials.gov processed this record on August 27, 2014