Clinical trial NCT00010517: Acupuncture in the Treatment of Depression
Official title: Acupuncture in the Treatment of Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depressive Disorders
Depression
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2001-02-05
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
Study officials:
affiliation: University of Arizona, Department of Psychology
name: John J. Allen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Allen JJ, Schnyer RN, Chambers AS, Hitt SK, Moreno FA, Manber R. Acupuncture for depression: a randomized controlled trial. J Clin Psychiatry. 2006 Nov;67(11):1665-73. doi: 10.4088/jcp.v67n1101.