Effectiveness of Acupuncture for Depressed Patients Taking Antidepressant Medications
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effectiveness of Acupuncture Augmentation on Treatment Resistant Depressed Patients|
- 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 ] [ Designated as safety issue: Yes ]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%.
- 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 ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2007|
|Study Completion Date:||April 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
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).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01633996
|United States, Massachusetts|
|Depression Clinical and Research Program, Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Albert Yeung, MD, ScD||Depression Clinical and Research Program, Massachusetts General Hospital|