Effectiveness of Acupuncture for Depressed Patients Taking Antidepressant Medications

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness of Acupuncture Augmentation on Treatment Resistant Depressed Patients

Conditions
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Depression

Intervention / Treatment
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* Procedure: Acupuncture


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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%. | Baseline and all acupuncture sessions (weekly) for 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acupuncture, Antidepressant, Augmentation, Depression