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Effectiveness of Acupuncture for Depressed Patients Taking Antidepressant Medications

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Massachusetts General Hospital

关键词

抽象

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.

日期

最后验证: 06/30/2012
首次提交: 06/14/2012
提交的预估入学人数: 07/01/2012
首次发布: 07/05/2012
上次提交的更新: 07/01/2012
最近更新发布: 07/05/2012
实际学习开始日期: 07/31/2007
预计主要完成日期: 03/31/2010
预计完成日期: 03/31/2010

状况或疾病

Depression

干预/治疗

Procedure: Acupuncture

-

手臂组

干预/治疗
Experimental: Acupuncture
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).
Procedure: Acupuncture
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.

资格标准

有资格学习的年龄 18 Years 至 18 Years
有资格学习的性别All
接受健康志愿者
标准

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.

结果

主要结果指标

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. [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%.

次要成果指标

1. Evidence of acupuncture augmentation's tolerability and acceptability, as determined clinically by the participant and study doctor. [Once per acupuncture session (weekly) for 8 weeks]

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