Effectiveness of Acupuncture for Depressed Patients Taking Antidepressant Medications

NCT ID: NCT01633996

Last Updated: 2012-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2010-04-30

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.

Conditions

Depression

Keywords

Acupuncture; Antidepressant; Augmentation; Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Albert Yeung

Director of Primary Care Research, Depression Clinical and Research Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Albert Yeung, MD, ScD

Role: PRINCIPAL_INVESTIGATOR

Depression Clinical and Research Program, Massachusetts General Hospital

Locations

Depression Clinical and Research Program, Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 20692042 (View on PubMed)

Other Identifiers

2002-P-001899

Identifier Type: -

Identifier Source: org_study_id