Depression Clinical Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
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