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Electroacupuncture for Major Depression

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ClinicalTrials.gov Identifier: NCT00071110
Recruitment Status : Completed
First Posted : October 15, 2003
Results First Posted : January 11, 2010
Last Update Posted : January 11, 2010
Sponsor:
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single;   Primary Purpose: Treatment
Conditions Depression
Depressive Disorder
Interventions Procedure: Electroacupuncture
Procedure: Sham
Enrollment 57

Recruitment Details 57 Participants were recruited from March 2004 - May 2007 at the UPMC Shadyside Center for Complementary Medicine.
Pre-assignment Details Twenty-nine subjects were randomized to Sham and 28 to Electroacupuncture.
Arm/Group Title Electroacupuncture (EA) Sham Acupuncture (SA)
Hide Arm/Group Description 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. Needles placed laterally on the scalp, not corresponding to any traditional meridians. No electrical stimulation delivered.
Period Title: Overall Study
Started 28 29
Completed 28 25
Not Completed 0 4
Reason Not Completed
Protocol Violation             0             4
Arm/Group Title Electroacupuncture (EA) Sham Acupuncture (SA) Total
Hide Arm/Group Description 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. Needles placed laterally on the scalp, not corresponding to any traditional meridians. No electrical stimulation delivered. Total of all reporting groups
Overall Number of Baseline Participants 28 29 57
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 29 participants 57 participants
<=18 years
0
   0.0%
0
   0.0%
0.0
Between 18 and 65 years
28
 100.0%
25
  86.2%
53.0
>=65 years
0
   0.0%
4
  13.8%
4.0
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants 29 participants 57 participants
46.04  (11.32) 48.86  (13.12) 47.47  (12.35)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 29 participants 57 participants
Female
21
  75.0%
18
  62.1%
39.0
Male
7
  25.0%
11
  37.9%
18.0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 28 participants 29 participants 57 participants
28 29 57
1.Primary Outcome
Title Antidepressant Response, Defined as a Hamilton Depression Rating Scale Score Relative Decrease of 50 % or More and a Final Score < 10
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT, excluding the first four sham acupuncture subjects, whom the primary acupuncturist erred in treating. Although he correctly used the sham electricity procedure, for these subjects he placed needles in the verum electroacupuncture points of GV-20 and Yin tang.
Arm/Group Title Electroacupuncture (EA) Sham Acupuncture (SA)
Hide Arm/Group Description:
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.
Needles placed laterally on the scalp, not corresponding to any traditional meridians. No electrical stimulation delivered.
Overall Number of Participants Analyzed 28 25
Measure Type: Number
Unit of Measure: participants
11 11
2.Secondary Outcome
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)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT, excluding the first four sham acupuncture subjects, whom the primary acupuncturist erred in treating. Although he correctly used the sham electricity procedure, for these subjects he placed needles in the verum electroacupuncture points of GV-20 and Yin tang.
Arm/Group Title Electroacupuncture (EA) Sham Acupuncture (SA)
Hide Arm/Group Description:
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.
Needles placed laterally on the scalp, not corresponding to any traditional meridians. No electrical stimulation delivered.
Overall Number of Participants Analyzed 28 25
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.54  (6.92) -1.65  (7.98)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Electroacupuncture (EA), Sham Acupuncture (SA)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.32
Comments Statistic (t): -1.00
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
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)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT, excluding the first four sham acupuncture subjects, whom the primary acupuncturist erred in treating. Although he correctly used the sham electricity procedure, for these subjects he placed needles in the verum electroacupuncture points of GV-20 and Yin tang.
Arm/Group Title Electroacupuncture (EA) Sham Acupuncture (SA)
Hide Arm/Group Description:
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.
Needles placed laterally on the scalp, not corresponding to any traditional meridians. No electrical stimulation delivered.
Overall Number of Participants Analyzed 28 25
Mean (Standard Deviation)
Unit of Measure: Units on a scale
6.23  (13.62) 14.12  (17.54)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Electroacupuncture (EA), Sham Acupuncture (SA)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments Statistic (t): 1.56
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
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)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT, excluding the first four sham acupuncture subjects, whom the primary acupuncturist erred in treating. Although he correctly used the sham electricity procedure, for these subjects he placed needles in the verum electroacupuncture points of GV-20 and Yin tang.
Arm/Group Title Electroacupuncture (EA) Sham Acupuncture (SA)
Hide Arm/Group Description:
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.
Needles placed laterally on the scalp, not corresponding to any traditional meridians. No electrical stimulation delivered.
Overall Number of Participants Analyzed 28 25
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-1.04  (18.27) 6.81  (19.70)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Electroacupuncture (EA), Sham Acupuncture (SA)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.17
Comments Statistic (t): 1.40
Method t-test, 2 sided
Comments [Not Specified]
Time Frame Weekly assessments from Baseline to Post-Intervention endpoint
Adverse Event Reporting Description SEMI-STRUCTURED INTERVIEW FOR THE Udvalg Fur Kliniske Undersogesler (UKU) SIDE EFFECTS RATING SCALE From the University of Pittsburgh. Adapted by Tracy Flynn, M.S. Ed. and Benoit H. Mulsant, M.D. from: Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987). The UKU side effect rating scale. Acta Psychitr Scand 334(Suppl): 1-100
 
Arm/Group Title Electroacupuncture (EA) Sham Acupuncture (SA)
Hide Arm/Group Description 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. Needles placed laterally on the scalp, not corresponding to any traditional meridians. No electrical stimulation delivered.
All-Cause Mortality
Electroacupuncture (EA) Sham Acupuncture (SA)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Electroacupuncture (EA) Sham Acupuncture (SA)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/29 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Electroacupuncture (EA) Sham Acupuncture (SA)
Affected / at Risk (%) Affected / at Risk (%)
Total   23/28 (82.14%)   25/29 (86.21%) 
Cardiac disorders     
PALPITATIONS / TACHYCARDIA  [1]  2/28 (7.14%)  1/29 (3.45%) 
Gastrointestinal disorders     
NAUSEA / VOMITING  [2]  7/28 (25.00%)  3/29 (10.34%) 
DIARRHEA  [3]  1/28 (3.57%)  1/29 (3.45%) 
CONSTIPATION  [4]  0/28 (0.00%)  3/29 (10.34%) 
Metabolism and nutrition disorders     
WEIGHT LOSS   0/28 (0.00%)  2/29 (6.90%) 
Nervous system disorders     
TREMOR  [5]  0/28 (0.00%)  1/29 (3.45%) 
PARATHESIAS  [6]  0/28 (0.00%)  1/29 (3.45%) 
HEADACHE  [7]  8/28 (28.57%)  4/29 (13.79%) 
ACCOMMODATION DISTURBANCES  [8]  0/28 (0.00%)  1/29 (3.45%) 
ORTHOSTATIC DIZZINESS  [9]  3/28 (10.71%)  3/29 (10.34%) 
Psychiatric disorders     
CONCENTRATION DIFFICULTIES  [10]  0/28 (0.00%)  3/29 (10.34%) 
ASTHENIA / LASSITUDE / INCREASED FATIGUABILITY  [11]  1/28 (3.57%)  2/29 (6.90%) 
SLEEPINESS / SEDATION  [12]  1/28 (3.57%)  1/29 (3.45%) 
FAILING MEMORY  [13]  1/28 (3.57%)  1/29 (3.45%) 
TENSION / INNER UNREST  [14]  1/28 (3.57%)  3/29 (10.34%) 
INCREASED DURATION OF SLEEP:  [15]  3/28 (10.71%)  4/29 (13.79%) 
REDUCED DURATION OF SLEEP:  [16]  7/28 (25.00%)  7/29 (24.14%) 
INCREASED DREAM ACTIVITY  [17]  9/28 (32.14%)  12/29 (41.38%) 
EMOTIONAL INDIFFERENCE  [18]  2/28 (7.14%)  2/29 (6.90%) 
Renal and urinary disorders     
MICTURITION DISTURBANCES  [19]  0/28 (0.00%)  1/29 (3.45%) 
Reproductive system and breast disorders     
MENORRHAGIA  [20]  0/28 (0.00%)  1/29 (3.45%) 
DIMINISHED SEXUAL DESIRE   3/28 (10.71%)  5/29 (17.24%) 
ERECTILE DYSFUNCTION  [21]  0/28 (0.00%)  1/29 (3.45%) 
EJACULATORY DYSFUNCTION  [22]  0/28 (0.00%)  1/29 (3.45%) 
ORGASMIC DYSFUNCTION  [23]  7/28 (25.00%)  4/29 (13.79%) 
DRY VAGINA  [24]  1/28 (3.57%)  0/29 (0.00%) 
Skin and subcutaneous tissue disorders     
INCREASED TENDENCY TO SWEATING  [25]  3/28 (10.71%)  1/29 (3.45%) 
RASH  [26]  1/28 (3.57%)  2/29 (6.90%) 
PRURITUS   1/28 (3.57%)  1/29 (3.45%) 
PHOTOSENSITIVITY  [27]  2/28 (7.14%)  2/29 (6.90%) 
Indicates events were collected by systematic assessment
[1]
UKU Q29-PALPITATIONS / TACHYCARDIA: palpitation, feeling of rapid, strong and /or irregular heartbeats.
[2]
UKU Q23-NAUSEA / VOMITING: to be recorded on the basis of the last 3 days.
[3]
UKU Q24-DIARRHEA: increased frequency and or thinner consistency of feces.
[4]
UKU Q25-CONSTIPATION: reduced frequency of defection and/or thicker consistency of feces.
[5]
UKU Q15-TREMOR: this item comprises all forms of tremor.
[6]
UKU Q18-PARATHESIAS: pricking, creeping, or burning sensations in the skin.
[7]
UKU Q19-HEADACHE: on the scoring sheet headache is classified as (a) tension headache, (b) migraine, or (c) other forms of headache
[8]
UKU Q20-ACCOMMODATION DISTURBANCES: difficulty in seeing clearly or distinctly at close quarters (with or without glasses), whereas the patient sees clearly at a long distance (w/glasses if necessary)
[9]
UKU Q28-ORTHOSTATIC DIZZINESS: feeling of weakness, everything going black, buzzing in the ears, increasing tendency to faint when changing from supine or sitting position to upright position.
[10]
Udvalg Fur Kliniske Undersogesler (UKU) Question 1: CONCENTRATION DIFFICULTIES: difficulties in ability to concentrate, to collect one’s thoughts, or to sustain one’s attention.
[11]
Udvalg Fur Kliniske Undersogesler (UKU) Question 2: ASTHENIA / LASSITUDE / INCREASED FATIGUABILITY: the patient’s experience of lassitude and lack of endurance. The assessment is based upon the patient’s reported statements.
[12]
Udvalg Fur Kliniske Undersogesler (UKU) Question 3: SLEEPINESS / SEDATION: diminished ability to stay awake during the day. The assessment is based on clinical signs during the interview.
[13]
Udvalg Fur Kliniske Undersogesler (UKU) Q4-FAILING MEMORY: impaired memory. Assessment should be independent of any concentration difficulties.
[14]
Udvalg Fur Kliniske Undersogesler (UKU) Q6-TENSION / INNER UNREST: inability to relax, nervous restlessness. This item is to be assessed on the basis of the patient’s experience and must be distinguished from motor akathesia (Q16).
[15]
Udvalg Fur Kliniske Undersogesler (UKU) Q7-INCREASED DURATION OF SLEEP: this should be assessed on the basis of the average of sleep over the three preceding nights. The assessment is to be made in relation to the patient’s usual pre-illness state.
[16]
Udvalg Fur Kliniske Undersogesler (UKU) Q8-REDUCED DURATION OF SLEEP: should be assessed on the basis of the average of sleep over the three preceding nights. The assessment is to be made in relation to the patient’s usual pre-illness state.
[17]
Udvalg Fur Kliniske Undersogesler (UKU) Q9-INCREASED DREAM ACTIVITY: should be assessed independently of dream content and based on the average of sleep over the preceding nights in relation to the usual pre-illness dream activity.
[18]
Udvalg Fur Kliniske Undersogesler (UKU) Q10-EMOTIONAL INDIFFERENCE: a diminution of the patient’s empathy, leading to apathy.
[19]
UKU Q26-MICTURITION DISTURBANCES: feeling of difficulty in starting and or resistance to micturition, weaker stream and/or increased time of micturition. Should be assessed on the basis of the last 3 days.
[20]
UKU Q37-(Menstruating females only) MENORRHAGIA: hypermenorrhea, polymenorrhea, or metrorrhagia during the last 3 months (or since last assessment).
[21]
UKU Q43-(Sexually active males only) ERECTILE DYSFUNCTION: difficulty in attainting or maintaining an erection.
[22]
UKU Q44-(Sexually active males only) EJACULATORY DYSFUNCTION: dysfunction of the patient’s ability to control ejaculation. Includes (a) premature or (b) delayed ejaculation.
[23]
UKU Q45-(Sexually active females and males) ORGASMIC DYSFUNCTION: difficulty in obtaining and experiencing satisfactory orgasm.
[24]
Q46-(Sexually active females only) DRY VAGINA: dryness of vagina with sexual stimulation.
[25]
UKU Q30-INCREASED TENDENCY TO SWEATING: localized to the whole body, not only palms and soles of the foot.
[26]
UKU Q31-RASH: for scoring, the types of rashes are classified as (a) morbilliform, (b) petechial, (c) urticarial, (d) psoriataic, and (e) cannot be classified.
[27]
UKU Q33-PHOTOSENSITIVITY: increased sensitivity to sunlight.
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.
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
ClinicalTrials.gov Identifier: NCT00071110     History of Changes
Other Study ID Numbers: R21AT001218-01A1 ( U.S. NIH Grant/Contract )
First Submitted: October 10, 2003
First Posted: October 15, 2003
Results First Submitted: March 27, 2009
Results First Posted: January 11, 2010
Last Update Posted: January 11, 2010