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Trial record 60 of 3030 for:    China Medicine University Hospital

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

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ClinicalTrials.gov Identifier: NCT03452384
Recruitment Status : Completed
First Posted : March 2, 2018
Last Update Posted : March 5, 2018
Sponsor:
Information provided by (Responsible Party):
Kuan-Pin, National Science Council, Taiwan

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.


Condition or disease Intervention/treatment Phase
Major Depressive Disorder Other: Acupuncture Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acupuncture in Depression: From the Clinical Trial, Biomarkers to Molecular Biology
Actual Study Start Date : November 6, 2014
Actual Primary Completion Date : October 31, 2016
Actual Study Completion Date : October 31, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
Experimental: acupucture
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.
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).

Sham Comparator: control
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). The needles will be affixed with plastic O-rings and adhesive tapes. The needles with blunt tips will be quickly put onto the same acupoints used in real acupuncture without inserting into the skin.
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).




Primary Outcome Measures :
  1. The Change from Baseline Hamilton depression rating scale at 12 weeks [ Time Frame: weeks 0 (baseline) and 12 weeks ]
    This scale scores 0-64 points;The higher total score indicates a more severe


Secondary Outcome Measures :
  1. The Change from Baseline Pittsburgh sleep Quality Inventory rating scale at 12 weeks [ Time Frame: weeks 0 (baseline) and 8 weeks ]
    This scale scores 0-21 points;The higher total score indicates a more severe depression



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03452384


Locations
Taiwan
China Medical University Hospital
Taichung, Taiwan, 404
Sponsors and Collaborators
National Science Council, Taiwan
Investigators
Principal Investigator: Kaun-Pin Su, MD, PhD China Medical University Hospital, Tiawan

Responsible Party: Kuan-Pin, Chief of psychiatry, National Science Council, Taiwan
ClinicalTrials.gov Identifier: NCT03452384     History of Changes
Other Study ID Numbers: CMUH103-REC2-074
First Posted: March 2, 2018    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: March 2018

Keywords provided by Kuan-Pin, National Science Council, Taiwan:
Acupuncture
Traditional chinese medicine
Major depressive disorder

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders