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

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

Study Description

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 Design

• 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

Arms and Interventions

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).

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

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

More Information

• Responsible Party: Kuan-Pin, Chief of psychiatry, National Science Council, Taiwan
• ClinicalTrials.gov Identifier: NCT03452384
• Other Study ID Numbers: CMUH103-REC2-074
• First Posted: March 2, 2018
• 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