Electroacupuncture for Major Depression - Full Text View

Sponsor:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00071110

Purpose

This study will compare the safety, efficacy, and tolerability of electroacupuncture (EA) and sham electroacupuncture (SA) for the treatment of major depression.

Condition	Intervention	Phase
Depression Depressive Disorder	Procedure: Electroacupuncture Procedure: Sham	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment
Official Title:	Electroacupuncture for Major Depression: A Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Depression

U.S. FDA Resources

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Enrollment:	57
Study Start Date:	March 2004
Study Completion Date:	May 2007
Primary Completion Date:	May 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Electroacupuncture (EA).	Procedure: Electroacupuncture For subjects randomized to EA, needles were placed at points GV-20—on the crown of the head and yin tang—on the midline of the forehead roughly at the glabella and treated with electrical stimulation. 30 mm x 0.22 mm sterile stainless steel needles were placed obliquely to a depth of approximately 10 mm and were connected to face-microelectrodes which were connected to the Pantheon Research PENS-Electrostimulator. Electricity was provided at a frequency of 2 Hz and set to a voltage which resulted in the perception of a mild intensity stimulation.
Placebo Comparator: 2 Sham	Procedure: Sham For subjects randomized to SA, two needles were placed laterally on the scalp, 3 cuns superior to the temporal attachment of the helix of the ear. This point was selected as it does not correspond to any specific meridian acupuncture point. A disabled electrical cable was connected to the needles and the electrostimulator, with light blinking at 2 Hz but no electrical stimulation provided.

Arms

Assigned Interventions

Experimental: 1

Electroacupuncture (EA).

Procedure: Electroacupuncture

For subjects randomized to EA, needles were placed at points GV-20—on the crown of the head and yin tang—on the midline of the forehead roughly at the glabella and treated with electrical stimulation. 30 mm x 0.22 mm sterile stainless steel needles were placed obliquely to a depth of approximately 10 mm and were connected to face-microelectrodes which were connected to the Pantheon Research PENS-Electrostimulator. Electricity was provided at a frequency of 2 Hz and set to a voltage which resulted in the perception of a mild intensity stimulation.

Placebo Comparator: 2

Sham

Procedure: Sham

For subjects randomized to SA, two needles were placed laterally on the scalp, 3 cuns superior to the temporal attachment of the helix of the ear. This point was selected as it does not correspond to any specific meridian acupuncture point. A disabled electrical cable was connected to the needles and the electrostimulator, with light blinking at 2 Hz but no electrical stimulation provided.

Detailed Description:

Major depression is a common and serious mental illness. It is associated with a markedly lower quality of life, significant functional impairment, and premature death due to suicide or comorbid physical illness. Over the past 50 years, effective and safe treatments for major depression have been developed, including antidepressant pharmacotherapy, psychotherapy, and electroconvulsive therapy. However, many Americans who suffer from a depressive disorder either do not elect to receive one of these conventional treatments or do not complete an adequate course of treatment. A growing number of Americans with depression are choosing to be treated with complementary and alternative therapies. Acupuncture, in particular, is increasingly being used to treat depression even though only limited data support its safety and efficacy.

This study will use a randomized parallel-group design to compare the safety, efficacy, and tolerability of electroacupuncture (EA) and sham electroacupuncture (SA) for the treatment of major depression. Over a 15-month period, 60 adult outpatients with a major depressive disorder of mild or moderate severity (as defined by the DSM-IV) will be randomized to either 12 sessions of EA or SA to be provided over 6 weeks. Safety and symptomatic improvement (as measured with the Hamilton Rating Scale for Depression [HRSD]) will constitute the primary outcome measures. Tolerability and functional improvement will constitute secondary outcome measures.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Meet SCID criteria for a Major Depressive Disorder (Single or Recurrent) with a current major depressive episode of mild or moderate severity
Significant symptoms of depression (HRSD > 14)
Ability to communicate in English
Give informed consent in accordance with local IRB regulations

Exclusion Criteria:

Personal physician's recommendation against enrollment because the patient is physically unstable or for other reasons
Having been treated with acupuncture for any condition
History of seizure disorder or significant risk factors for a seizure disorder (e.g., history of brain trauma, recent stroke, or brain tumor)
Need to remain on antidepressant or other psychotropic medications
Absence of depressive symptoms severe enough (i.e., HRSD < 14) at the baseline assessments
Significant cognitive impairment, as assessed by a total score on the MMSE < 25. A recommendation for referral to a neurologist or a psychiatrist will be made to the patient in these cases.
Chronic major depression (i.e, duration of 2 years or longer) A recommendation for referral to a psychiatrist will be made in these cases.
Major depressive episode severe or severe with psychotic features (as per DSM-IV/SCID) or with acutely suicidality. A recommendation for psychiatric referral will be made in these cases. Bipolar disorder, psychotic features, or a psychotic disorder (specifically: schizophrenia, delusional disorder, or schizoaffective disorder). A recommendation for psychiatric referral will be made in these cases.
Met criteria for a diagnosis of alcohol substance abuse or dependence within the past six months. A recommendation for referral to a mental health professional will be made in these cases.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00071110

Locations

United States, Pennsylvania
UPMC Shadyside, Center for Complementary Medicine
Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

Benoit H Mulsant, MD

University of Pittsburgh

More Information

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

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):

Acupuncture
Electroacupuncture
Alternative therapy

Additional relevant MeSH terms:

Depression
Depressive Disorder
Depressive Disorder, Major

Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on February 12, 2012