Effectiveness of Acupuncture for Depressed Patients Not Taking Antidepressant Medications
Acupuncture is a popular complementary/alternative therapy that has been in use for thousands of years for the treatment of various medical and psychiatric conditions, including Major Depressive Disorder (MDD). In this study, the investigators applied the investigators acupuncture-treatment-for-depression protocol, based on Traditional Chinese Medicine (TCM) principles for treating MDD, to depressed patients not taking any antidepressant medications (a protocol that the investigators previously piloted as a medication augmentation therapy for partial responders with MDD).
The investigators specifically investigated the efficacy, safety, and tolerability of this TCM-based protocol for such patients, as well as potential differences in outcomes between weekly vs. twice-weekly treatment. The investigators hypothesized that acupuncture monotherapy 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 on Treating Major Depressive Disorder|
- Change in scores on the Hamilton Depression Rating Scale, 17 items (HAM-D-17) [ Time Frame: Baseline and all acupuncture sessions (weekly) for 8 weeks ] [ Designated as safety issue: Yes ]The HAM-D-17 is a clinician-rated assessment (structured interview) of patients' depressive symptoms. Questions focus on depressive symptoms during the past 7 days, and higher cumulative scores (possible responses to each item range from 0-4 or 0-2) indicate more severe depression.
- Response to treatment, defined as a 50% or greater improvement in HAM-D-17 score compared to baseline [ Time Frame: Baseline and all acupuncture sessions (weekly) for 8 weeks ] [ Designated as safety issue: Yes ](See primary outcome measure description.)
|Study Start Date:||May 2005|
|Study Completion Date:||November 2011|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
Adults with depression who are not currently taking an antidepressant medication.
5 specific body acupoints (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 min. Two acupoints along the midline of the head, GV-20 and GV-24.5 (Yintang), were also used with a 2 Hz current applied from GV-20 (−) to GV24.5 (+).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01634022
|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|