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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00010517
Other study ID # R01 AT000001-01M
Secondary ID R01 AT000001-01
Status Completed
Phase Phase 3
First received February 2, 2001
Last updated March 5, 2008
Start date September 1997
Est. completion date April 2002

Study information

Verified date March 2008
Source National Center for Complementary and Integrative Health (NCCIH)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The current large randomized placebo-controlled trial is testing the ability of acupuncture to treat major depression. The study is unique in that treatment effects will be from the perspective of both Western psychiatry and Chinese medicine.


Description:

Depression is an unfortunately common condition for which people often seek alternative (non-Western) treatments, perhaps because conventional treatments do not consistently provide lasting relief. A pilot study (Allen, Schnyer and Hitt, 1998) suggests that acupuncture, a popular but under-researched alternative treatment derived from Chinese medicine, holds sufficient promise as a treatment for depression to warrant a larger-scale clinical trial. The investigators propose to conduct a larger-scale test of the efficacy of acupuncture in this trial. Because relapse and recurrence of Major Depression are quite common, the investigators also will assess the clinical status of participants for 18 months after treatment concludes. In the first phase of this double-blind randomized clinical trial, 150 men and women meeting criteria for Major Depression will be randomly assigned to a treatment approach or to a waitlist control. All participants will ultimately receive acupuncture designed to address their own particular constellation of depressive symptoms. At the end of this first phase, blind assessments will be used to compare treatment effects from the perspectives of both Western psychiatry and Chinese medicine. After this treatment phase, participants will be assessed several times over the next 18 months. The study is designed to evaluate the efficacy and clinical significance of acupuncture as a treatment for Major Depression, and to examine the convergence of Western-based and Chinese-medicine-based outcome measures. Finally, the study will determine whether changes in energetic pattern mediate changes in Western defined depression severity, and explore whether patient and history variables predict responses to acupuncture treatments.


Other known NCT identifiers
  • NCT00004534

Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date April 2002
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Must meet criteria for Major Depression.

- Must be free of other mental or physical disorders that could cause depression, and also free from conditions that would typically exclude participants from trials involving pharmacologic antidepressants.

- Cannot be receiving other treatments or require immediate clinical attention.

Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Acupuncture


Locations

Country Name City State
United States University of Arizona Tucson Arizona

Sponsors (1)

Lead Sponsor Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

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