DepressionNCT01558154
Comparison of Treatment Effect of Chinese Medicine and Western Medicine on Depression in China and America
A study testing Chinese herbs, acupuncture and Psychotherapy in people with Depression, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
Comparison of different assessment methods to evaluate the treatment efficacy of Chinese medicine on minor and mild depression. Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Depression
- What is being tested?
- Chinese herbs, acupuncture and Psychotherapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- Mar 2012to Jul 2014
- 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 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- According with ICD-10 criteria of depression;
- Age 16-70;
- Antidepressant and other Psychiatric drugs have not been had two weeks before the trial, or the drugs above had been used but have cleaning period of two weeks;
- Level of education is higher than junior middle school;
- Course of disease is more than two weeks;
- Volunteer to join and Signed the informed consent
Who cannot join
- Pregnancy or lactation;
- Severe depression or have serious suicidal tendencies
- long distance or other causes who can not adherence to treatment
Trial locations and contacts
1 site in 1 country.
China1 site
Guang'anmen Hospital
Beijing, Beijing Municipality, 100053
Xue Yan, doctor, 86-10-88001178, snowater27@hotmail.com
Xueyu Lv, doctor, 86-10-88001178, yuyu1208@163.com
About this study
Comparison of different assessment methods to evaluate the treatment efficacy of Chinese medicine on minor and mild depression.
Read the detailed description
Significant differences show on the evaluation of treatment efficacy of Chinese medicine on depression in China and America. Choose minor and mild depression patients as trials. One hundred and sixty trials will be included and randomly divided into Chinese medicine group (n=40), acupuncture group (n=40), traditional Chinese medicine psychology group (n=40) and physical treatment group (n=40). Time points of assessment are before treatment, 1 week, 2 weeks, 4weeks, 6 weeks and 12 weeks post treatment.The assessment tools are series of psychological questionnaires. And study the mechanism of treatment efficacy assessment variances by different methods.
- Conditions
- Depression
- Being tested
- Chinese herbs, acupuncture, Psychotherapy, Transcranial magnetic stimulation
- Keywords
- depression, Chinese herb, acupuncture, Psychotherapy, Transcranial magnetic stimulation
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese herbsDrug
Chinese herbs special for depression
acupunctureProcedure or surgery
six acupuncture point including DU20, EX HN3, EX HN1, PC6,HT7,SP6,special for depression
PsychotherapyOther
Thought Imprint Psychotherapy under lower Resistance State
Transcranial magnetic stimulationDevice
Give magnetic stimulation at head
| Study group | Role | What they receive |
|---|---|---|
| Chinese herb | Experimental | Chinese herbs special for depression Receives: Drug: Chinese herbs |
| acupuncture | Experimental | Not described Receives: Procedure: acupuncture |
| Psychotherapy | Experimental | Not described Receives: Other: Psychotherapy |
| physiotherapy | Experimental | Not described Receives: Device: Transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
psychological questionnaires
Measured: 12 weeks post treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionMar 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- California Pacific Medical Center Research Institute, Massachusetts General Hospital
- Responsible party
- Principal investigator, Xue Yan, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Weidong Wang, master, Study chair, Guang'anmen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01558154
- Sponsor's protocol ID
- 2011DFA30960
- Status last verified
- Mar 2012
- First submitted
- 2 Mar 2012
- Last updated
- 20 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Treatment Effect of Chinese Medicine and Western Medicine on Depression in China and America
- ClinicalTrials.gov ID
- NCT01558154
- Acronym / sponsor ID
- 2011DFA30960
- Conditions
- Depression
- Keywords
- depression, Chinese herb, acupuncture, Psychotherapy, Transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- California Pacific Medical Center Research Institute, Massachusetts General Hospital
- Study start
- Mar 2012
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 20 Mar 2012 (estimated)
- 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.
Comparison of different assessment methods to evaluate the treatment efficacy of Chinese medicine on minor and mild depression.
Detailed description
Significant differences show on the evaluation of treatment efficacy of Chinese medicine on depression in China and America. Choose minor and mild depression patients as trials. One hundred and sixty trials will be included and randomly divided into Chinese medicine group (n=40), acupuncture group (n=40), traditional Chinese medicine psychology group (n=40) and physical treatment group (n=40). Time points of assessment are before treatment, 1 week, 2 weeks, 4weeks, 6 weeks and 12 weeks post treatment.The assessment tools are series of psychological questionnaires. And study the mechanism of treatment efficacy assessment variances by different methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Chinese herb | Experimental | Drug: Chinese herbsChinese herbs special for depression |
| acupuncture | Experimental | Procedure: acupuncture |
| Psychotherapy | Experimental | Other: Psychotherapy |
| physiotherapy | Experimental | Device: Transcranial magnetic stimulation |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- According with ICD-10 criteria of depression;
- Age 16-70;
- Antidepressant and other Psychiatric drugs have not been had two weeks before the trial, or the drugs above had been used but have cleaning period of two weeks;
- Level of education is higher than junior middle school;
- Course of disease is more than two weeks;
Key exclusion criteria (3 listed)
- Pregnancy or lactation;
- Severe depression or have serious suicidal tendencies
- long distance or other causes who can not adherence to treatment
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 |
|---|---|---|
| Chinese herbsChinese herbs special for depression | Drug | Chinese herb |
| acupuncturesix acupuncture point including DU20, EX HN3, EX HN1, PC6,HT7,SP6,special for depression | Procedure or surgery | acupuncture |
| PsychotherapyThought Imprint Psychotherapy under lower Resistance State | Other | Psychotherapy |
| Transcranial magnetic stimulationGive magnetic stimulation at head | Device | physiotherapy |
Primary outcome
psychological questionnaires
Time frame: 12 weeks post treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2012.
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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.
Weidong Wang, master study chair
Guang'anmen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chinese herbs, acupuncture and Psychotherapy in people with Depression, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 20 Mar 2012. 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 China. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weidong Wang, Master (86-10-88001261, pro_wwd@sohu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
psychological questionnaires (time frame: 12 weeks post treatment.). 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 20 Mar 2012.