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Completed

NCT Number: NCT01633996

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.

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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

  • Ages 18-65
  • A HAM-D-17 score of >= 14
  • Partial or nonresponse to a standard antidepressant (monotherapy or combination) at an adequate dose over the past 8 or more weeks (natural agents such as omega-3 fatty acids, St John's wort, SAMe, and folic acid, were allowed as antidepressants)
  • Concurrent psychotherapy was allowed, provided that it was not initiated within the 3 months prior to study entry.

Exclusion criteria

  • A 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 major depression and not some other condition, including any form of substance abuse or dependence within the last 6 months, other medical conditions that could be the basis of a 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 had not been stable for at least 3 months
  • Having had electroconvulsive therapy (ECT) during the past year
  • Current active suicidal or self-injurious potential necessitating immediate treatment.

Treatment and study plan

Acupuncture

Procedure

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.

Primary outcomes

  1. 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%.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Effectiveness of Acupuncture Augmentation on Treatment Resistant Depressed Patients

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
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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