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Completed

NCT Number: NCT01634022

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Depression Clinical and Research Program, Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acupuncture

Procedure

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 (+).

Primary outcomes

  1. 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

    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 outcomes

  1. 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

    (See primary outcome measure description.)

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Effectiveness of Acupuncture on Treating Major Depressive Disorder

Important dates

Study start
2005
Primary completion
2011
Study completion
2011
First posted
Jul 6, 2012
Registry last updated
Jul 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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