Effectiveness of Acupuncture for Depressed Patients Taking Antidepressant Medications
|ClinicalTrials.gov Identifier: NCT01633996|
Recruitment Status : Completed
First Posted : July 6, 2012
Last Update Posted : July 6, 2012
|Condition or disease||Intervention/treatment||Phase|
|Depression||Procedure: Acupuncture||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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%.
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|