Condition category
Mental and Behavioural Disorders
Date applied
10/12/2007
Date assigned
04/03/2008
Last edited
16/05/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Zhang-Jin Zhang

ORCID ID

Contact details

School of Chinese Medicine
The University of Hong Kong
10 Sassoon Road
Pokfulam
-
Hong Kong

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A single-blind, randomised, sham controlled study of electroacupuncture in accelerating the onset of antidepressant action of selective serotonin reuptake inhibitors via serotonergic mechanisms

Acronym

Study hypothesis

Depression is a worldwide mental health problem, with a lifetime prevalence of about 20%. The currently available antidepressant treatments, represented by selective serotonin reuptake inhibitors (SSRIs), are incomplete and unsatisfactory. The most apparent is the delay in the onset of action of SSRIs, which has hampered the use of this class of drugs.

Hypothesis:
Electroacupuncture acceleration of the response to SSRIs is achieved through its potentiation of serotonin (5-HT) release by inhibiting autoreceptor (5-HT1A/1B) activities, uptake, and turnover.

Ethics approval

Ethics approval received from the Medical Ethical Committee of the First Teaching Hospital, Hebei Medical University on the 19th June 2006 (ref: 66).

Study design

A single-centre, single-blind, randomised, sham controlled study.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Depression

Intervention

This is a six-week, single-blind, randomised, sham controlled study. A total of 66 untreated patients with MDD will be recruited. Under single-blind condition, patients will be randomly assigned to paroxetine (PRX) combined with active or sham electroacupuncture (EA) for six weeks. PRX dose is initiated at 10 mg/day and escalated to maximum 40 mg/day within one week. EA intervention is conducted by electrically stimulating two acupoints: Yin-Tang (EX-HN3) and Bai-Hui (DU-20) for 45 minutes daily.

Both groups of the patients will receive orally administered PRX for six weeks. The dose is initiated at 10 mg/day and escalated to maximum 40 mg/day within one week. The choice of PRX, but not other SSRIs, is because the slow onset of PRX action has been well demonstrated in our preliminary and previous studies. Treatments with the dose range defined have been reported to yield optimal clinical outcomes in Chinese depressed patients. Concomitant use of other psychoactive medications is not allowed. If significantly clinical conditions have to require such medications, patients will be asked to withdraw from the study. Patients who have poor compliance with medication schedules (below 80%) will also be removed from the study.

Meanwhile, active or sham EA intervention is conducted daily for six weeks. For active EA, a pair of stainless steel needles of 0.25 mm diameter are inserted at a depth of 10 - 20 mm obliquely into Bai-Hui (Du-20) and Yin-Tang (EX-HN3), through which electric stimulation with continuous waves with 2 Hz at 6 voltages are delivered. The intensities of stimulation are adjusted to a level at which patients feel most comfortable. To ensure the active procedure as identical as the sham procedure, the inserted needles are affixed with adhesive tapes. For the sham treatment, the needles are inserted into two non-traditionally defined points at 1 - 1.5 cm around the acupoints used for active EA, but immediately taken out and put back into plastic needle guiding tubes. The needles contained in the tubes are then affixed on the point skins with adhesive tapes and stimulated electrically as described above. Our initial practice and other studies have demonstrated that this novel sham acupuncture procedure enables well-controlled blinding for patients.

Intervention type

Drug

Phase

Not Specified

Drug names

Paroxetine

Primary outcome measures

1. Efficacy, measured using the HAMD-17, CGI-S, and Sheehan disability scale (SDS)
2. Adverse events, assessed using the treatment emergent symptom scale (TESS)

Assessments will be conducted at baseline and at day 3, 7, 10, 14, 21, 28, 35, and 42.

Secondary outcome measures

1. Clinical response, defined as less than 50% reduction from baseline on HAMD-17
2. Remission, defined as a score 7 points or less on the HAMD-17

Assessments will be conducted at baseline and at day 3, 7, 10, 14, 21, 28, 35, and 42.

Overall trial start date

01/09/2006

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Either gender aged 25 - 65 years
2. Have first-episode major depressive disorder (MDD) diagnosed from the diagnostic and statistical manual of mental disorders, 4th edition (DSM-IV)
3. Scores on the 17-item Hamilton depression rating scale (HAMD) and clinical global impression of severity (CGI-S) are at least 20 and 4 points, respectively
4. Have not yet received any psychoactive medications

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

66

Participant exclusion criteria

1. Unstable medical conditions
2. Have suicidal attempts or aggressive behaviour
3. Previously experienced manic, hypomanic, or mixed episode
4. Immediate family members were or are diagnosed for bipolar or psychotic disorders
5. Treatment with investigational drugs in past six months
6. Alcoholism or drug abuse in past one year
7. Have needle phobia

Recruitment start date

01/09/2006

Recruitment end date

31/12/2010

Locations

Countries of recruitment

China, Hong Kong

Trial participating centre

School of Chinese Medicine
Pokfulam
-
Hong Kong

Sponsor information

Organisation

The Health and Health Services Research Fund (HHSRF), Food and Health Bureau of Hong Kong

Sponsor details

18/F
Murray Building
Garden Road
Central
Hong Kong
Hong Kong
050031
China

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

The First Teaching Hospital (China) - Intramural Research Fund

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22238631

Publication citations

  1. Results

    Zhang ZJ, Ng R, Man SC, Li TY, Wong W, Tan QR, Wong HK, Chung KF, Wong MT, Tsang WK, Yip KC, Ziea E, Wong VT, Dense cranial electroacupuncture stimulation for major depressive disorder--a single-blind, randomized, controlled study., PLoS ONE, 2012, 7, 1, e29651, doi: 10.1371/journal.pone.0029651.

Additional files

Editorial Notes