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.
- 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
- 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
- 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.