Effectiveness of Acupuncture for Depressed Patients Not Taking Antidepressant Medications

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness of Acupuncture on Treating Major Depressive Disorder

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: 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.

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>Adults with depression who are not currently taking an antidepressant medication. | Procedure: Acupuncture<br>* 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 (+).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in scores on the Hamilton Depression Rating Scale, 17 items (HAM-D-17) | 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. | Baseline and all acupuncture sessions (weekly) for 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to treatment, defined as a 50% or greater improvement in HAM-D-17 score compared to baseline | (See primary outcome measure description.) | Baseline and all acupuncture sessions (weekly) for 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antidepressant, Monotherapy, Depression, Alternative treatments, Acupuncture