Clinical trial NCT03452384: Acupuncture in Depression: From the Clinical Trial, Biomarkers to Molecular Biology
Official title: Acupuncture in Depression: From the Clinical Trial, Biomarkers to Molecular Biology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Acupuncture
Traditional chinese medicine
Major depressive disorder
Lead sponsor: National Science and Technology Council, Taiwan
Sponsor class: OTHER_GOV
First posted: 2018-03-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of major depressive disorder (MDD)
* Over 18 on the 21-item Hamilton Rating Scale for Depression

Exclusion Criteria:

* Schizophrenia
* Ubstance dependence disorders

Primary outcomes:
measure: The Change from Baseline Hamilton depression rating scale at 12 weeks
timeFrame: weeks 0 (baseline) and 12 weeks
Secondary outcomes:
measure: The Change from Baseline Pittsburgh sleep Quality Inventory rating scale at 12 weeks
timeFrame: weeks 0 (baseline) and 8 weeks
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: China Medical University Hospital, Tiawan
name: Kaun-Pin Su, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: