Major Depressive DisorderNCT03452384
Acupuncture in Depression: From the Clinical Trial, Biomarkers to Molecular Biology
A study testing Acupuncture in people with Major Depressive Disorder, run by National Science and Technology Council, Taiwan at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Nov 2014to 31 Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of major depressive disorder (MDD)
- Over 18 on the 21-item Hamilton Rating Scale for Depression
Who cannot join
- Schizophrenia
- Ubstance dependence disorders
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Major Depressive Disorder
- Being tested
- Acupuncture
- Keywords
- Acupuncture, Traditional chinese medicine, Major depressive disorder
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: weeks 0 (baseline) and 12 weeks
Secondary outcomes (1)
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
Measured: weeks 0 (baseline) and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2018
- Study start6 Nov 2014
- Primary completion31 Oct 2016
- Study completion31 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Science and Technology Council, Taiwan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Kuan-Pin, National Science and Technology Council, Taiwan
- Investigators
- Kaun-Pin Su, MD, PhD, Principal investigator, China Medical University Hospital, Tiawan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03452384
- Sponsor's protocol ID
- CMUH103-REC2-074
- Status last verified
- Mar 2018
- First submitted
- 4 May 2015
- Last updated
- 5 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture in Depression: From the Clinical Trial, Biomarkers to Molecular Biology
- ClinicalTrials.gov ID
- NCT03452384
- Acronym / sponsor ID
- CMUH103-REC2-074
- Conditions
- Major Depressive Disorder
- Keywords
- Acupuncture, Traditional chinese medicine, Major depressive disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Science and Technology Council, TaiwanOther government
- Study start
- 6 Nov 2014 (actual)
- Primary completion
- 31 Oct 2016 (actual)
- Study completion
- 31 Oct 2016 (actual)
- First posted
- 2 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acupucture | Experimental | Other: AcupunctureFor 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. |
| control | Sham comparator | Other: AcupunctureFor 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of major depressive disorder (MDD)
- Over 18 on the 21-item Hamilton Rating Scale for Depression
Key exclusion criteria (2 listed)
- Schizophrenia
- Ubstance dependence disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureFor 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). | Other | acupucture, control |
Primary outcome
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
1 secondary outcome
The Change from Baseline Pittsburgh sleep Quality Inventory rating scale at 12 weeks
Time frame: weeks 0 (baseline) and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kaun-Pin Su, MD, PhD principal investigator
China Medical University Hospital, Tiawan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Major Depressive Disorder, run by National Science and Technology Council, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Change from Baseline Hamilton depression rating scale at 12 weeks (time frame: weeks 0 (baseline) and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2018.