Electroacupuncture for Major Depression

This study has been completed.

Study NCT00071110 Information provided by National Center for Complementary and Alternative Medicine (NCCAM)

First Received on October 10, 2003. Last Updated on December 4, 2009 History of Changes

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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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.

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 ]

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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 ]

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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 ]

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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 ]

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Serious Adverse Events

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Other Adverse Events

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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.

Limitations and Caveats

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.

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:

Andreescu C, Glick RM, Emeremni CA, Houck PR, Mulsant BH. Acupuncture for the treatment of major depressive disorder: a randomized controlled trial. J Clin Psychiatry. 2011 Aug;72(8):1129-35. Epub 2011 May 3.

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