Acupuncture in Depression: From the Clinical Trial, Biomarkers to Molecular Biology

NCT03452384 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-03-05

No results posted yet for this study

Summary

Major depressive disorder (MDD) is a serious psychiatric illness with a high lifetime prevalence rate and causes major clinical, social and economic burden to patients and their family. Despite more than 40 antidepressants with various mechanisms are available on the market, half of patients fail to achieve remission with optimized medication treatment. Due to unsatisfactory efficacy, frequent intolerability and poor compliance of psychopharmacotherapies, novel and safe alternative therapies are critically in need to improve the treatment of depression.

Traditional Chinese medicine (TCM) theory describes a state of health maintained by a balance of energy in the body. If imbalanced, it can be corrected by acupuncture, the insertion of fine needles into different parts of the body. Although there are several clinical trials to demonstrate the antidepressant effects of acupuncture, its biological and physiological mechanisms are still unknown. In addition, clinical depression is frequently accompanied with somatic presentations, which are related to autonomic nervous dysfunction. It would be of interest to know if acupuncture could regulate autonomic nervous system (ANS) and improve the somatic symptoms in depression. The purpose of this study is to assess the effectiveness of acupuncture in the treatment of depression and to determine the influence of acupuncture on the molecular and ANS systems.

Conditions

Interventions

OTHER

Acupuncture

For real acupuncture, disposable acupuncture needles (0.22 x 30-mm sterile stainless needles) were inserted into acupoints for a depth of 10-30 mm in a direction oblique or parallel to the surface. To ensure allocation concealment, the inserted needles were affixed with adhesive tapes so that real acupuncture procedure will be identical to control acupuncture procedure. For sham acupuncture procedure, Streitberger's noninvasive placebo acupuncture needles will be used. Its validity and credibility have been well demonstrated (Streitberger and Kleinhenz, 1998).

Sponsors & Collaborators

  • National Science and Technology Council, Taiwan

    lead OTHER_GOV

Principal Investigators

  • Kaun-Pin Su, MD, PhD · China Medical University Hospital, Tiawan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-06
Primary Completion
2016-10-31
Completion
2016-10-31

Countries

  • Taiwan

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03452384 on ClinicalTrials.gov