Effectiveness of Acupuncture for Depressed Patients Not Taking Antidepressant Medications

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Albert Yeung, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01634022
First received: June 15, 2012
Last updated: July 2, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Depression
Procedure: Acupuncture

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.)


Enrollment: 64
Study Start Date: May 2005
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acupuncture
Adults with depression who are not currently taking an antidepressant medication.
Procedure: Acupuncture
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 (+).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has current or past DSM-IV MDD diagnosis based on SCID; AND current 17-Hamilton Rating Scale for Depression (BRSD) score of 14 or above
  • Age between 18-65
  • No treatment with antidepressant(s) in the past 3 months
  • If patient has received psychotherapy, no initiation or termination of therapy in the past 3 months.

Exclusion Criteria:

  • Patients with 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 MDD and not some other condition, including substance abuse or dependence within the last 6 months, medical conditions that could produce 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 have not been stable for at least 3 months.
  • Electroconvulsive therapy (ECT) during the last year.
  • Current active suicidal or self-injurious potential necessitating immediate treatment.
  • Currently receiving concomitant Acupuncture Treatment, or any Acupuncture treatment in the past three months.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01634022

Locations
United States, Massachusetts
Depression Clinical and Research Program, Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Albert Yeung, MD, ScD Depression Clinical and Research Program, Massachusetts General Hospital
  More Information

Publications:
Responsible Party: Albert Yeung, Director of Primary Care Research, Depression Clinical and Research Program, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01634022     History of Changes
Other Study ID Numbers: 2004P002819
Study First Received: June 15, 2012
Last Updated: July 2, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Acupuncture
Antidepressant
Monotherapy
Depression
Alternative treatments

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014