Major Depressive Disorder Clinical Trial
Official title:
Acupuncture in Depression: From the Clinical Trial, Biomarkers to Molecular Biology
Verified date | March 2018 |
Source | National Science Council, Taiwan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | October 31, 2016 |
Est. primary completion date | October 31, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Taiwan | China Medical University Hospital | Taichung |
Lead Sponsor | Collaborator |
---|---|
National Science Council, Taiwan |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Change from Baseline Hamilton depression rating scale at 12 weeks | This scale scores 0-64 points;The higher total score indicates a more severe | weeks 0 (baseline) and 12 weeks | |
Secondary | The Change from Baseline Pittsburgh sleep Quality Inventory rating scale at 12 weeks | This scale scores 0-21 points;The higher total score indicates a more severe depression | weeks 0 (baseline) and 8 weeks |
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