Acupuncture in the Treatment of Depression

Sponsor
National Center for Complementary and Integrative Health (NCCIH) (NIH)
Overall Status
Completed
CT.gov ID
NCT00010517
Collaborator
(none)
1
55

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Acupuncture
Phase 3

Detailed 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.

Study Design

Study Type:
Interventional
Allocation:
Randomized
Masking:
Double
Primary Purpose:
Treatment
Official Title:
Acupuncture in the Treatment of Depression
Study Start Date :
Sep 1, 1997
Study Completion Date :
Apr 1, 2002

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Arizona Tucson Arizona United States 85721-0068

    Sponsors and Collaborators

    • National Center for Complementary and Integrative Health (NCCIH)

    Investigators

    • Principal Investigator: John J. Allen, PhD, University of Arizona, Department of Psychology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00010517
    Other Study ID Numbers:
    • R01 AT000001-01M
    • R01AT000001-01
    • NCT00004534
    First Posted:
    Feb 5, 2001
    Last Update Posted:
    Mar 7, 2008
    Last Verified:
    Mar 1, 2008
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 7, 2008