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Comparison of Treatment Effect of Chinese Medicine and Western Medicine on Depression in China and America

Primary Purpose

Depression

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Chinese herbs
acupuncture
Psychotherapy
Transcranial magnetic stimulation
Sponsored by
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring depression, Chinese herb, acupuncture, Psychotherapy, Transcranial magnetic stimulation

Eligibility Criteria

16 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Pregnancy or lactation;
  • Severe depression or have serious suicidal tendencies
  • long distance or other causes who can not adherence to treatment

Sites / Locations

  • Guang'anmen Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Chinese herb

acupuncture

Psychotherapy

physiotherapy

Arm Description

Chinese herbs special for depression

Outcomes

Primary Outcome Measures

psychological questionnaires

Secondary Outcome Measures

Full Information

First Posted
March 2, 2012
Last Updated
March 16, 2012
Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborators
California Pacific Medical Center Research Institute, Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01558154
Brief Title
Comparison of Treatment Effect of Chinese Medicine and Western Medicine on Depression in China and America
Official Title
Comparison of Treatment Effect of Chinese Medicine and Western Medicine on Depression in China and America
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
March 2014 (Anticipated)
Study Completion Date
July 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborators
California Pacific Medical Center Research Institute, Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
depression, Chinese herb, acupuncture, Psychotherapy, Transcranial magnetic stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chinese herb
Arm Type
Experimental
Arm Description
Chinese herbs special for depression
Arm Title
acupuncture
Arm Type
Experimental
Arm Title
Psychotherapy
Arm Type
Experimental
Arm Title
physiotherapy
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Chinese herbs
Intervention Description
Chinese herbs special for depression
Intervention Type
Procedure
Intervention Name(s)
acupuncture
Intervention Description
six acupuncture point including DU20, EX HN3, EX HN1, PC6,HT7,SP6,special for depression
Intervention Type
Other
Intervention Name(s)
Psychotherapy
Intervention Description
Thought Imprint Psychotherapy under lower Resistance State
Intervention Type
Device
Intervention Name(s)
Transcranial magnetic stimulation
Intervention Description
Give magnetic stimulation at head
Primary Outcome Measure Information:
Title
psychological questionnaires
Time Frame
12 weeks post treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Pregnancy or lactation; Severe depression or have serious suicidal tendencies long distance or other causes who can not adherence to treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weidong Wang, Master
Phone
86-10-88001261
Email
pro_wwd@sohu.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xue Yan, Doctor
Phone
86-10-88001178
Email
snowater27@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weidong Wang, master
Organizational Affiliation
Guang'anmen Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Guang'anmen Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xue Yan, doctor
Phone
86-10-88001178
Email
snowater27@hotmail.com
First Name & Middle Initial & Last Name & Degree
Xueyu Lv, doctor
Phone
86-10-88001178
Email
yuyu1208@163.com

12. IPD Sharing Statement

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Comparison of Treatment Effect of Chinese Medicine and Western Medicine on Depression in China and America

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