Electroacupuncture for Major Depression
Condition: Depression; Depressive Disorder
MeSH terms: Depression; Depressive Disorder
Intervention: Electroacupuncture; Sham
Intervention description: 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.; 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Acupuncture; Electroacupuncture; Alternative therapy

Summary:

      This study will compare the safety, efficacy, and tolerability of electroacupuncture (EA) and
      sham electroacupuncture (SA) for the treatment of major depression.
    

Eligibility criteria:

        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.