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Sponsored by: |
National Center for Complementary and Alternative Medicine (NCCAM) |
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Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
ClinicalTrials.gov Identifier: | NCT00071110 |
This study will compare the safety, efficacy, and tolerability of electroacupuncture (EA) and sham electroacupuncture (SA) for the treatment of major depression.
Condition | Intervention | Phase |
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Depression Depressive Disorder |
Procedure: electroacupuncture |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Electroacupuncture for Major Depression: A Pilot Study |
Estimated Enrollment: | 60 |
Study Start Date: | March 2004 |
Study Completion Date: | May 2007 |
Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Pennsylvania | |
UPMC Shadyside, Center for Complementary Medicine | |
Pittsburgh, Pennsylvania, United States, 15213 |
Principal Investigator: | Benoit H Mulsant, MD | University of Pittsburgh |
Study ID Numbers: | R21 AT001218-01A1 |
Study First Received: | October 10, 2003 |
Last Updated: | August 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00071110 |
Health Authority: | United States: Federal Government |
Acupuncture Electroacupuncture Alternative therapy |
Depression Mental Disorders Mood Disorders |
Depressive Disorder, Major Depressive Disorder Behavioral Symptoms |