Effectiveness of Acupuncture for Depressed Patients Taking Antidepressant Medications

NCT01633996 | Completed

• 1 other identifier: 2002-P-001899
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (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.

  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%.

  Baseline and all acupuncture sessions (weekly) for 8 weeks

Secondary Outcomes (1)

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

  Once per acupuncture session (weekly) for 8 weeks

Study Arms (1)

Acupuncture

EXPERIMENTAL

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

Interventions

Acupuncture 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.

Acupuncture

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Depression Clinical and Research Program, Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• 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.

  PMID: 20692042 RESULT

MeSH Terms

Conditions

Depression

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Albert Yeung, MD, ScD

  Depression Clinical and Research Program, Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Primary Care Research, Depression Clinical and Research Program

Study Record Dates

• First Submitted: June 15, 2012
• First Posted: July 6, 2012
• Study Start: August 1, 2007
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: July 6, 2012

Record last verified: 2012-07

Locations

US (1)