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This study will compare the safety, efficacy, and tolerability of electroacupuncture (EA) and sham electroacupuncture (SA) for the treatment of major depression.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Electroacupuncture (EA). |
|
| 2 | Placebo Comparator | Sham |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electroacupuncture | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from Baseline to Post-Intervention Endpoint |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benoit H Mulsant, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Shadyside, Center for Complementary Medicine | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21672495 | Derived | 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. |
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Twenty-nine subjects were randomized to Sham and 28 to Electroacupuncture.
57 Participants were recruited from March 2004 - May 2007 at the UPMC Shadyside Center for Complementary Medicine.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Sham Acupuncture (SA) | Needles placed laterally on the scalp, not corresponding to any traditional meridians. No electrical stimulation delivered. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Sham Acupuncture (SA) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Number | participants | Change from Baseline to Post-Intervention Endpoint |
|
Weekly assessments from Baseline to Post-Intervention endpoint
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
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CONCENTRATION DIFFICULTIES | Psychiatric disorders | Systematic Assessment | 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. |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Benoit H. Mulsant, MD | University of Pittsburgh | (416) 535-8501 | 3655 | benoit_mulsant@camh.net |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D003866 | Depressive Disorder |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015671 | Electroacupuncture |
| C005703 | salicylhydroxamic acid |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D015670 | Acupuncture Therapy |
| D000529 | Complementary Therapies |
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|
| Sham | Procedure | 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. |
|
| Mean Change from Baseline to Post-Intervention Endpoint |
| 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). | Mean Change from Baseline to Post-Intervention Endpoint |
| 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). | Mean Change from Baseline to Post-Intervention Endpoint |
Needles placed laterally on the scalp, not corresponding to any traditional meridians. No electrical stimulation delivered. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Sham Acupuncture (SA) | Needles placed laterally on the scalp, not corresponding to any traditional meridians. No electrical stimulation delivered. |
|
|
| 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) | 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). | 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. | Posted | Apr 2009 | Mean | Standard Deviation | Units on a scale | Mean Change from Baseline to Post-Intervention Endpoint |
|
|
|
|
| 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) | 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). | 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. | Posted | Mean | Standard Deviation | Units on a scale | Mean Change from Baseline to Post-Intervention Endpoint |
|
|
|
|
| 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) | 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). | 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. | Posted | Mean | Standard Deviation | Units on a scale | Mean Change from Baseline to Post-Intervention Endpoint |
|
|
|
|
| 0 |
| 28 |
| 23 |
| 28 |
| EG001 | Sham Acupuncture (SA) | Needles placed laterally on the scalp, not corresponding to any traditional meridians. No electrical stimulation delivered. | 0 | 29 | 25 | 29 |
|
| ASTHENIA / LASSITUDE / INCREASED FATIGUABILITY | Psychiatric disorders | Systematic Assessment | 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. |
|
| SLEEPINESS / SEDATION | Psychiatric disorders | Systematic Assessment | 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. |
|
| FAILING MEMORY | Psychiatric disorders | Systematic Assessment | Udvalg Fur Kliniske Undersogesler (UKU) Q4-FAILING MEMORY: impaired memory. Assessment should be independent of any concentration difficulties. |
|
| TENSION / INNER UNREST | Psychiatric disorders | Systematic Assessment | 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). |
|
| INCREASED DURATION OF SLEEP: | Psychiatric disorders | Systematic Assessment | 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. |
|
| REDUCED DURATION OF SLEEP: | Psychiatric disorders | Systematic Assessment | 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. |
|
| INCREASED DREAM ACTIVITY | Psychiatric disorders | Systematic Assessment | 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. |
|
| EMOTIONAL INDIFFERENCE | Psychiatric disorders | Systematic Assessment | Udvalg Fur Kliniske Undersogesler (UKU) Q10-EMOTIONAL INDIFFERENCE: a diminution of the patient's empathy, leading to apathy. |
|
| TREMOR | Nervous system disorders | Systematic Assessment | UKU Q15-TREMOR: this item comprises all forms of tremor. |
|
| PARATHESIAS | Nervous system disorders | Systematic Assessment | UKU Q18-PARATHESIAS: pricking, creeping, or burning sensations in the skin. |
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| HEADACHE | Nervous system disorders | Systematic Assessment | UKU Q19-HEADACHE: on the scoring sheet headache is classified as (a) tension headache, (b) migraine, or (c) other forms of headache |
|
| ACCOMMODATION DISTURBANCES | Nervous system disorders | Systematic Assessment | 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) |
|
| NAUSEA / VOMITING | Gastrointestinal disorders | Systematic Assessment | UKU Q23-NAUSEA / VOMITING: to be recorded on the basis of the last 3 days. |
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| DIARRHEA | Gastrointestinal disorders | Systematic Assessment | UKU Q24-DIARRHEA: increased frequency and or thinner consistency of feces. |
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| CONSTIPATION | Gastrointestinal disorders | Systematic Assessment | UKU Q25-CONSTIPATION: reduced frequency of defection and/or thicker consistency of feces. |
|
| MICTURITION DISTURBANCES | Renal and urinary disorders | Systematic Assessment | 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. |
|
| ORTHOSTATIC DIZZINESS | Nervous system disorders | Systematic Assessment | 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. |
|
| PALPITATIONS / TACHYCARDIA | Cardiac disorders | Systematic Assessment | UKU Q29-PALPITATIONS / TACHYCARDIA: palpitation, feeling of rapid, strong and /or irregular heartbeats. |
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| INCREASED TENDENCY TO SWEATING | Skin and subcutaneous tissue disorders | Systematic Assessment | UKU Q30-INCREASED TENDENCY TO SWEATING: localized to the whole body, not only palms and soles of the foot. |
|
| RASH | Skin and subcutaneous tissue disorders | Systematic Assessment | 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. |
|
| PRURITUS | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| PHOTOSENSITIVITY | Skin and subcutaneous tissue disorders | Systematic Assessment | UKU Q33-PHOTOSENSITIVITY: increased sensitivity to sunlight. |
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| WEIGHT LOSS | Metabolism and nutrition disorders | Systematic Assessment |
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| MENORRHAGIA | Reproductive system and breast disorders | Systematic Assessment | UKU Q37-(Menstruating females only) MENORRHAGIA: hypermenorrhea, polymenorrhea, or metrorrhagia during the last 3 months (or since last assessment). |
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| DIMINISHED SEXUAL DESIRE | Reproductive system and breast disorders | Systematic Assessment |
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| ERECTILE DYSFUNCTION | Reproductive system and breast disorders | Systematic Assessment | UKU Q43-(Sexually active males only) ERECTILE DYSFUNCTION: difficulty in attainting or maintaining an erection. |
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| EJACULATORY DYSFUNCTION | Reproductive system and breast disorders | Systematic Assessment | UKU Q44-(Sexually active males only) EJACULATORY DYSFUNCTION: dysfunction of the patient's ability to control ejaculation. Includes (a) premature or (b) delayed ejaculation. |
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| ORGASMIC DYSFUNCTION | Reproductive system and breast disorders | Systematic Assessment | UKU Q45-(Sexually active females and males) ORGASMIC DYSFUNCTION: difficulty in obtaining and experiencing satisfactory orgasm. |
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| DRY VAGINA | Reproductive system and breast disorders | Systematic Assessment | Q46-(Sexually active females only) DRY VAGINA: dryness of vagina with sexual stimulation. |
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| D004599 |
| Electric Stimulation Therapy |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D004561 | Transcutaneous Electric Nerve Stimulation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D000758 | Anesthesia |