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Electroacupuncture for Major Depression

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00071110
First received: October 10, 2003
Last updated: December 4, 2009
Last verified: December 2009
Results First Received: March 27, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind;   Primary Purpose: Treatment
Conditions: Depression
Depressive Disorder
Interventions: Procedure: Electroacupuncture
Procedure: Sham

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
57 Participants were recruited from March 2004 - May 2007 at the UPMC Shadyside Center for Complementary Medicine.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Twenty-nine subjects were randomized to Sham and 28 to Electroacupuncture.

Reporting Groups
  Description
Electroacupuncture (EA) Needles placed at traditional meridian locations, GV-20 (on the crown of the head) and yin tang (in the midline of the forehead roughly at the glabella) and treated with electrical stimulation.
Sham Acupuncture (SA) Needles placed laterally on the scalp, not corresponding to any traditional meridians. No electrical stimulation delivered.

Participant Flow:   Overall Study
    Electroacupuncture (EA)     Sham Acupuncture (SA)  
STARTED     28     29  
COMPLETED     28     25  
NOT COMPLETED     0     4  
Protocol Violation                 0                 4  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Electroacupuncture (EA) Needles placed at traditional meridian locations, GV-20 (on the crown of the head) and yin tang (in the midline of the forehead roughly at the glabella) and treated with electrical stimulation.
Sham Acupuncture (SA) Needles placed laterally on the scalp, not corresponding to any traditional meridians. No electrical stimulation delivered.
Total Total of all reporting groups

Baseline Measures
    Electroacupuncture (EA)     Sham Acupuncture (SA)     Total  
Number of Participants  
[units: participants]
  28     29     57  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     28     25     53  
>=65 years     0     4     4  
Age  
[units: years]
Mean ± Standard Deviation
  46.04  ± 11.32     48.86  ± 13.12     47.47  ± 12.35  
Gender  
[units: participants]
     
Female     21     18     39  
Male     7     11     18  
Region of Enrollment  
[units: participants]
     
United States     28     29     57  



  Outcome Measures
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1.  Primary:   Antidepressant Response, Defined as a Hamilton Depression Rating Scale Score Relative Decrease of 50 % or More and a Final Score < 10   [ Time Frame: Change from Baseline to Post-Intervention Endpoint ]

2.  Secondary:   Change in Functioning and Health-related Quality of Life as Rated by the Medical Outcomes Survey-Version 1 (MOS-36) Physical Component Score (MOSPCS)   [ Time Frame: Mean Change from Baseline to Post-Intervention Endpoint ]

3.  Secondary:   Change in Functioning and Health-related Quality of Life as Rated by the Medical Outcomes Survey-Version 1 (MOS-36) Mental Component Score (MOSMCS)   [ Time Frame: Mean Change from Baseline to Post-Intervention Endpoint ]

4.  Secondary:   Change in Functioning and Health-related Quality of Life as Rated by the Medical Outcomes Survey-Version 1 (MOS-36) Bodily Pain Index (MOSBPI)   [ Time Frame: Mean Change from Baseline to Post-Intervention Endpoint ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Four participants were excluded from the analyses because of a protocol violation. In the Sham Acupuncture group, the acupuncturist placed unelectrified needles in GV-20 and Yin tang points instead of placing them laterally.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Benoit H. Mulsant, MD
Organization: University of Pittsburgh
phone: (416) 535-8501 ext 3655
e-mail: benoit_mulsant@camh.net


No publications provided by National Center for Complementary and Alternative Medicine (NCCAM)

Publications automatically indexed to this study:

ClinicalTrials.gov Identifier: NCT00071110     History of Changes
Other Study ID Numbers: R21 AT001218-01A1
Study First Received: October 10, 2003
Results First Received: March 27, 2009
Last Updated: December 4, 2009
Health Authority: United States: Federal Government