Electroacupuncture for Major Depression
Condition: Depression; Depressive Disorder
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Electroacupuncture; Sham
Intervention type(s): Procedure; Procedure
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Acupuncture; Electroacupuncture; Alternative therapy