DepressionPhase 2NCT00071110
Electroacupuncture for Major Depression
A Phase 2 study testing Electroacupuncture in people with Depression and Depressive Disorder, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial summary
This study will compare the safety, efficacy, and tolerability of electroacupuncture (EA) and sham electroacupuncture (SA) for the treatment of major depression. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Depression, Depressive Disorder
- What is being tested?
- Electroacupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to May 2007
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Shadyside, Center for Complementary Medicine
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Electroacupuncture for Major Depression: A Pilot Study
This study will compare the safety, efficacy, and tolerability of electroacupuncture (EA) and sham electroacupuncture (SA) for the treatment of major depression.
Read the 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.
- Conditions
- Depression, Depressive Disorder
- Being tested
- Electroacupuncture, Sham
- Keywords
- Acupuncture, Electroacupuncture, Alternative therapy
- Medical subject headings
- Depression, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroacupunctureProcedure or surgery
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.
ShamProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Electroacupuncture (EA). Receives: Procedure: Electroacupuncture |
| 2 | Placebo comparator | Sham Receives: Procedure: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline to Post-Intervention Endpoint
Secondary outcomes (3)
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).
Measured: 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).
Measured: 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).
Measured: Mean Change from Baseline to Post-Intervention Endpoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2003 (estimated)
- Study startMar 2004
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Benoit H Mulsant, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00071110
- Sponsor's protocol ID
- R21AT001218-01A1
- Status last verified
- Dec 2009
- First submitted
- 10 Oct 2003
- Last updated
- 11 Jan 2010
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 21672495
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroacupuncture for Major Depression: A Pilot Study
- ClinicalTrials.gov ID
- NCT00071110
- Acronym / sponsor ID
- R21AT001218-01A1
- Conditions
- Depression, Depressive Disorder
- Keywords
- Acupuncture, Electroacupuncture, Alternative therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Mar 2004
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 15 Oct 2003 (estimated)
- Results
- Posted 11 Jan 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: ElectroacupunctureElectroacupuncture (EA). |
| 2 | Placebo comparator | Procedure: ShamSham |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectroacupunctureFor 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. | Procedure or surgery | 1 |
| ShamFor 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. | Procedure or surgery | 2 |
Primary outcome
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
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.
3 secondary outcomes
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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21672495Andreescu 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benoit H Mulsant, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Electroacupuncture in people with Depression and Depressive Disorder, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jan 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00071110, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2010.