Depression, Depressive Disorder
Conditions
Keywords
Acupuncture, Electroacupuncture, Alternative therapy
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.
Interventions
PROCEDUREElectroacupuncture
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.
PROCEDURESham
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.
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antidepressant Response, Defined as a Hamilton Depression Rating Scale Score Relative Decrease of 50 % or More and a Final Score < 10 | Change from Baseline to Post-Intervention Endpoint | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 from Baseline to Post-Intervention Endpoint | 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 from Baseline to Post-Intervention Endpoint | 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 from Baseline to Post-Intervention Endpoint | 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). |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 28 |
| Sham Acupuncture (SA) Needles placed laterally on the scalp, not corresponding to any traditional meridians. No electrical stimulation delivered. | 29 |
| Total | 57 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 0 | 4 |
Baseline characteristics
| Characteristic | Sham Acupuncture (SA) | Electroacupuncture (EA) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0.0 Participants |
| Age, Categorical >=65 years | 4 Participants | 0 Participants | 4.0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 28 Participants | 53.0 Participants |
| Age Continuous | 48.86 years STANDARD_DEVIATION 13.12 | 46.04 years STANDARD_DEVIATION 11.32 | 47.47 years STANDARD_DEVIATION 12.35 |
| Region of Enrollment United States | 29 participants | 28 participants | 57.0 participants |
| Sex: Female, Male Female | 18 Participants | 21 Participants | 39.0 Participants |
| Sex: Female, Male Male | 11 Participants | 7 Participants | 18.0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 23 / 28 | 25 / 29 |
| serious Total, serious adverse events | 0 / 28 | 0 / 29 |
Outcome results
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.
Time frame: Change from Baseline to Post-Intervention Endpoint
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Electroacupuncture (EA) | Antidepressant Response, Defined as a Hamilton Depression Rating Scale Score Relative Decrease of 50 % or More and a Final Score < 10 | 11 participants |
| Sham Acupuncture (SA) | Antidepressant Response, Defined as a Hamilton Depression Rating Scale Score Relative Decrease of 50 % or More and a Final Score < 10 | 11 participants |
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).
Time frame: Mean Change from Baseline to Post-Intervention Endpoint
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Electroacupuncture (EA) | Change in Functioning and Health-related Quality of Life as Rated by the Medical Outcomes Survey-Version 1 (MOS-36) Bodily Pain Index (MOSBPI) | -1.04 Units on a scale | Standard Deviation 18.27 |
| Sham Acupuncture (SA) | Change in Functioning and Health-related Quality of Life as Rated by the Medical Outcomes Survey-Version 1 (MOS-36) Bodily Pain Index (MOSBPI) | 6.81 Units on a scale | Standard Deviation 19.7 |
p-value: 0.17t-test, 2 sided
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).
Time frame: Mean Change from Baseline to Post-Intervention Endpoint
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Electroacupuncture (EA) | Change in Functioning and Health-related Quality of Life as Rated by the Medical Outcomes Survey-Version 1 (MOS-36) Mental Component Score (MOSMCS) | 6.23 Units on a scale | Standard Deviation 13.62 |
| Sham Acupuncture (SA) | Change in Functioning and Health-related Quality of Life as Rated by the Medical Outcomes Survey-Version 1 (MOS-36) Mental Component Score (MOSMCS) | 14.12 Units on a scale | Standard Deviation 17.54 |
p-value: 0.09t-test, 2 sided
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).
Time frame: Mean Change from Baseline to Post-Intervention Endpoint
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Electroacupuncture (EA) | Change in Functioning and Health-related Quality of Life as Rated by the Medical Outcomes Survey-Version 1 (MOS-36) Physical Component Score (MOSPCS) | 0.54 Units on a scale | Standard Deviation 6.92 |
| Sham Acupuncture (SA) | Change in Functioning and Health-related Quality of Life as Rated by the Medical Outcomes Survey-Version 1 (MOS-36) Physical Component Score (MOSPCS) | -1.65 Units on a scale | Standard Deviation 7.98 |
p-value: 0.32t-test, 2 sided