Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00071110
Status:
COMPLETED
Last Update Posted:
2010-01-11
First Post:
2003-10-10
Brief Title:
Electroacupuncture for Major Depression
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
Electroacupuncture for Major Depression A Pilot Study
Status:
COMPLETED
Status Verified Date:
2009-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None