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

NCT03452384 | Completed

• 1 other identifier: CMUH103-REC2-074
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

Acupuncture; Traditional chinese medicine; Major depressive disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The Change from Baseline Pittsburgh sleep Quality Inventory rating scale at 12 weeks

  weeks 0 (baseline) and 8 weeks

Study Arms (2)

acupucture

EXPERIMENTAL

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

control

SHAM COMPARATOR

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

Interventions

Acupuncture OTHER

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).

acupucture; control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Schizophrenia
• Ubstance dependence disorders

Sponsors & Collaborators

• National Science and Technology Council, Taiwan: lead

Study Sites (1)

China Medical University Hospital

Taichung, 404, Taiwan

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Kaun-Pin Su, MD, PhD

  China Medical University Hospital, Tiawan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of psychiatry

Study Record Dates

• First Submitted: May 4, 2015
• First Posted: March 2, 2018
• Study Start: November 6, 2014
• Primary Completion: October 31, 2016
• Study Completion: October 31, 2016
• Last Updated: March 5, 2018

Record last verified: 2018-03

Locations

TW (1)