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Effectiveness of Acupuncture for Depressed Patients Taking Antidepressant Medications

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Acupuncture, Antidepressant, Augmentation, Depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Depression Clinical and Research Program, Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Acupuncture

Arm Description

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).

Outcomes

Primary Outcome Measures

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.
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

Evidence of acupuncture augmentation's tolerability and acceptability, as determined clinically by the participant and study doctor.

Full Information

First Posted
June 15, 2012
Last Updated
July 2, 2012
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01633996
Brief Title
Effectiveness of Acupuncture for Depressed Patients Taking Antidepressant Medications
Official Title
Effectiveness of Acupuncture Augmentation on Treatment Resistant Depressed Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Acupuncture, Antidepressant, Augmentation, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture
Arm Type
Experimental
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Intervention Description
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 Measure Information:
Title
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.
Description
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%.
Time Frame
Baseline and all acupuncture sessions (weekly) for 8 weeks
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert Yeung, MD, ScD
Organizational Affiliation
Depression Clinical and Research Program, Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Depression Clinical and Research Program, Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20692042
Citation
Yeung AS, Ameral VE, Chuzi SE, Fava M, Mischoulon D. A pilot study of acupuncture augmentation therapy in antidepressant partial and non-responders with major depressive disorder. J Affect Disord. 2011 Apr;130(1-2):285-9. doi: 10.1016/j.jad.2010.07.025. Epub 2010 Aug 6.
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Effectiveness of Acupuncture for Depressed Patients Taking Antidepressant Medications

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