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Electroacupuncture for Major Depression

Primary Purpose

Depression, Depressive Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Electroacupuncture
Sham
Sponsored by
National Center for Complementary and Integrative Health (NCCIH)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Acupuncture, Electroacupuncture, Alternative therapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UPMC Shadyside, Center for Complementary Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Electroacupuncture (EA).

Sham

Outcomes

Primary Outcome Measures

Antidepressant Response, Defined as a Hamilton Depression Rating Scale Score Relative Decrease of 50 % or More and a Final Score < 10
Number of participants whose Hamilton Depression Rating Scale score decreased at least 50% and had a final score less than 10. Minimum score = 0 (best). Maximum score = 52 (worst). The 17 item scale assesses depression symptoms, including Depressed Mood, Feelings of Guilt, Suicidal Ideation, Insomnia, Anxiety, Weight Change, and Insight.

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)
Mean change in scores on the Medical Outcomes Survey-Version 1 (MOS-36) PHYSICAL Component Score (MOSPCS) from baseline to post-intervention across treatment group. Minimum Score = 0 (worse); Maximum Score = 100 (better), Normed to be at 50 on a control population. Positive Mean Change scores indicate improvement (an increase in scale score/better).
Change in Functioning and Health-related Quality of Life as Rated by the Medical Outcomes Survey-Version 1 (MOS-36) Mental Component Score (MOSMCS)
Mean change in scores on the Medical Outcomes Survey-Version 1 (MOS-36) Mental Component Score (MOSMCS) from baseline to post-intervention across treatment group. Minimum Score = 0 (worse); Maximum Score = 100 (better) , Normed to be at 50 on a control population. Positive Mean Change scores indicate improvement (an increase in scale score).
Change in Functioning and Health-related Quality of Life as Rated by the Medical Outcomes Survey-Version 1 (MOS-36) Bodily Pain Index (MOSBPI)
Mean change in scores on the Medical Outcomes Survey-Version 1 (MOS-36) Bodily Pain Index (MOSBPI) from baseline to post-intervention across treatment group. Minimum Score = 0 (more); Maximum Score = 100 (less). Positive Mean Change scores indicate improvement (an increase in scale score/less pain).

Full Information

First Posted
October 10, 2003
Last Updated
December 4, 2009
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00071110
Brief Title
Electroacupuncture for Major Depression
Official Title
Electroacupuncture for Major Depression: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Depressive Disorder
Keywords
Acupuncture, Electroacupuncture, Alternative therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Electroacupuncture (EA).
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Sham
Intervention Type
Procedure
Intervention Name(s)
Electroacupuncture
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Sham
Intervention Description
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.
Primary Outcome Measure Information:
Title
Antidepressant Response, Defined as a Hamilton Depression Rating Scale Score Relative Decrease of 50 % or More and a Final Score < 10
Description
Number of participants whose Hamilton Depression Rating Scale score decreased at least 50% and had a final score less than 10. Minimum score = 0 (best). Maximum score = 52 (worst). The 17 item scale assesses depression symptoms, including Depressed Mood, Feelings of Guilt, Suicidal Ideation, Insomnia, Anxiety, Weight Change, and Insight.
Time Frame
Change from Baseline to Post-Intervention Endpoint
Secondary Outcome Measure Information:
Title
Change in Functioning and Health-related Quality of Life as Rated by the Medical Outcomes Survey-Version 1 (MOS-36) Physical Component Score (MOSPCS)
Description
Mean change in scores on the Medical Outcomes Survey-Version 1 (MOS-36) PHYSICAL Component Score (MOSPCS) from baseline to post-intervention across treatment group. Minimum Score = 0 (worse); Maximum Score = 100 (better), Normed to be at 50 on a control population. Positive Mean Change scores indicate improvement (an increase in scale score/better).
Time Frame
Mean Change from Baseline to Post-Intervention Endpoint
Title
Change in Functioning and Health-related Quality of Life as Rated by the Medical Outcomes Survey-Version 1 (MOS-36) Mental Component Score (MOSMCS)
Description
Mean change in scores on the Medical Outcomes Survey-Version 1 (MOS-36) Mental Component Score (MOSMCS) from baseline to post-intervention across treatment group. Minimum Score = 0 (worse); Maximum Score = 100 (better) , Normed to be at 50 on a control population. Positive Mean Change scores indicate improvement (an increase in scale score).
Time Frame
Mean Change from Baseline to Post-Intervention Endpoint
Title
Change in Functioning and Health-related Quality of Life as Rated by the Medical Outcomes Survey-Version 1 (MOS-36) Bodily Pain Index (MOSBPI)
Description
Mean change in scores on the Medical Outcomes Survey-Version 1 (MOS-36) Bodily Pain Index (MOSBPI) from baseline to post-intervention across treatment group. Minimum Score = 0 (more); Maximum Score = 100 (less). Positive Mean Change scores indicate improvement (an increase in scale score/less pain).
Time Frame
Mean Change from Baseline to Post-Intervention Endpoint

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benoit H Mulsant, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPMC Shadyside, Center for Complementary Medicine
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21672495
Citation
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. doi: 10.4088/JCP.10m06105. Epub 2011 May 3.
Results Reference
derived

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Electroacupuncture for Major Depression

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