Acupuncture in Depression: From the Clinical Trial, Biomarkers to Molecular Biology
Condition: Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

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.
    

Detailed description: 
      In this study,the investigators will test the antidepressant effect of acupuncture versus
      sham intervention on major depression, in an eight-week, double-blind, randomized-controlled
      trial in 40 MDD patients who still have significant depressive symptoms without changing at
      their treatment modality for the last 4 weeks. During the visits at weeks 0 (baseline), 1, 2,
      4, 6, 8 (intervention), and 12 (4 weeks after intervention), subjects will be assessed
      depressive symptoms with the 21-item Hamilton Rating Scale for Depression (HAM-D). Before and
      after the intervention (Weeks 0 and 8),Computerized TCM constitution diagnosis will be
      measured and the blood samples will be collected for biomarker analyses, including
      neurotransmitter, inflammatory molecules and immunologic function. All parts of this research
      will start after being approved by the Institution Review Board in study sites.

      The outcomes of this study could provide the evidence of applying acupuncture as an
      alternative effective treatment for depression and to improve the understanding of biological
      mechanisms for its antidepressant effects.
    

Intervention name(s): Acupuncture
Intervention type(s): Other
Intervention description(s): 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).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acupuncture; Traditional chinese medicine; Major depressive disorder