- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00010517
Acupuncture in the Treatment of Depression
March 5, 2008 updated by: National Center for Complementary and Integrative Health (NCCIH)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Tucson, Arizona, United States, 85721-0068
- University of Arizona
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: John J. Allen, PhD, University of Arizona, Department of Psychology
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 1997
Study Completion
April 1, 2002
Study Registration Dates
First Submitted
February 2, 2001
First Submitted That Met QC Criteria
February 2, 2001
First Posted (Estimate)
February 5, 2001
Study Record Updates
Last Update Posted (Estimate)
March 7, 2008
Last Update Submitted That Met QC Criteria
March 5, 2008
Last Verified
March 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01 AT000001-01M
- R01AT000001-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Depression
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ProgenaBiomeRecruitingDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
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Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
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Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryRecruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
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University of California, San FranciscoRecruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
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University GhentUniversiteit Antwerpen; Janssen-Cilag Ltd.RecruitingDepression Moderate | Depression Severe | Depression MildBelgium
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Baylor College of MedicineUniversity of TexasRecruitingDepression | Depression Moderate | Depression Severe | Suicide and Self-harm | Depression in Adolescence | Depression MildUnited States
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University of Cape TownNational Institute of Mental Health (NIMH)CompletedPostpartum Depression | Clinical Depression | Moderate DepressionSouth Africa
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Washington University School of MedicinePatient-Centered Outcomes Research Institute; National Institute of Mental...CompletedMajor Depressive Disorder | Treatment Resistant Depression | Treatment-Refractory Depression | Late Life Depression | Geriatric DepressionUnited States, Canada
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Lawson Health Research InstituteTerminated
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Northern Illinois UniversityUniversity Autonoma de Santo DomingoTerminatedDepression Moderate | Depression MildUnited States, Dominican Republic
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