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Effectiveness of Acupuncture for Depressed Patients Taking Antidepressant Medications

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01633996
Recruitment Status : Completed
First Posted : July 6, 2012
Last Update Posted : July 6, 2012
Information provided by (Responsible Party):
Albert Yeung, Massachusetts General Hospital

Brief Summary:
In this research study, the investigators piloted a uniform acupuncture treatment protocol among adults with depression who were taking an antidepressant medication that was providing only partial or no symptom alleviation. The study's aims were evaluate the efficacy, safety, and tolerability of acupuncture augmentation treatment among this population. The investigators hypothesized that acupuncture as an augmentation treatment would be associated with a response rate of at least 50%, which the investigators defined as a decrease in depressive symptoms from the beginning to the end of the study of 50% or more, and that the response would be greater among patients who received acupuncture 2 times per week (vs. 1 time per week). The investigators also hypothesized that acupuncture would be associated with minimal side effects.

Condition or disease Intervention/treatment Phase
Depression Procedure: Acupuncture Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Acupuncture Augmentation on Treatment Resistant Depressed Patients
Study Start Date : August 2007
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
Experimental: Acupuncture
All participants received open acupuncture augmentation treatment per the uniform acupuncture treatment protocol that we developed according to Traditional Chinese Medicine (TCM) principles for treating depression (see Intervention Description).
Procedure: Acupuncture
Our acupuncture treatment protocol included: HT-7 and LI-4 on the hands bilaterally, and ST-36, SP-6, and LR-3 on the legs bilaterally, with gentle manual tonification every 10 minutes; and GV-20 and GV- 24.5 (Yintang), along the midline of the head.

Primary Outcome Measures :
  1. Response to acupuncture augmentation treatment, defined as a change in scores on the Hamilton Depression Rating Scale, 17 items (HAM-D-17) from baseline to endpoint. [ Time Frame: Baseline and all acupuncture sessions (weekly) for 8 weeks ]
    The HAM-D-17 is a clinician-rated measure of patient depressive symptoms (structured interview). Higher cumulative scores indicate more severe depression. A 50% or greater reduction in HAM-D-17 from baseline to endpoint was considered representative of our hypothesized acupuncture-augmentation response rate of at least 50%.

Secondary Outcome Measures :
  1. Evidence of acupuncture augmentation's tolerability and acceptability, as determined clinically by the participant and study doctor. [ Time Frame: Once per acupuncture session (weekly) for 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Ages 18-65
  • A HAM-D-17 score of >= 14
  • Partial or nonresponse to a standard antidepressant (monotherapy or combination) at an adequate dose over the past 8 or more weeks (natural agents such as omega-3 fatty acids, St John's wort, SAMe, and folic acid, were allowed as antidepressants)
  • Concurrent psychotherapy was allowed, provided that it was not initiated within the 3 months prior to study entry.

Exclusion Criteria:

  • A primary diagnosis other than major depressive disorder, or any history of psychosis or mania
  • Conditions that could make it difficult to conclusively determine that depressive symptoms were the result of major depression and not some other condition, including any form of substance abuse or dependence within the last 6 months, other medical conditions that could be the basis of a depression (including epilepsy, history of an abnormal EEG, severe head trauma, or stroke)
  • Serious uncontrolled medical conditions (e.g. poorly controlled diabetes, severe congestive heart failure), or other medical conditions that had not been stable for at least 3 months
  • Having had electroconvulsive therapy (ECT) during the past year
  • Current active suicidal or self-injurious potential necessitating immediate treatment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01633996

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United States, Massachusetts
Depression Clinical and Research Program, Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
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Principal Investigator: Albert Yeung, MD, ScD Depression Clinical and Research Program, Massachusetts General Hospital

Publications of Results:
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Responsible Party: Albert Yeung, Director of Primary Care Research, Depression Clinical and Research Program, Massachusetts General Hospital Identifier: NCT01633996    
Other Study ID Numbers: 2002-P-001899
First Posted: July 6, 2012    Key Record Dates
Last Update Posted: July 6, 2012
Last Verified: July 2012
Keywords provided by Albert Yeung, Massachusetts General Hospital:
Additional relevant MeSH terms:
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Behavioral Symptoms