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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01558154
• Other study ID #: 2011DFA30960
• Status: Not yet recruiting
• Phase: N/A
• First received: March 2, 2012
• Last updated: March 16, 2012
• Start date: March 2012
• Est. completion date: July 2014

Study information

• Verified date: March 2012
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: Weidong Wang, Master
• Phone: 86-10-88001261
• Email: pro_wwd[@]sohu.com
• Is FDA regulated: No
• Health authority: China: State Administration of Traditional Chinese Medicine
• Study type: Interventional

Clinical Trial Summary

Comparison of different assessment methods to evaluate the treatment efficacy of Chinese medicine on minor and mild depression.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: July 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Drug:
• Chinese herbs
Chinese herbs special for depression

Procedure:
• acupuncture
six acupuncture point including DU20, EX HN3, EX HN1, PC6,HT7,SP6,special for depression

Other:
• Psychotherapy
Thought Imprint Psychotherapy under lower Resistance State

Device:
• Transcranial magnetic stimulation
Give magnetic stimulation at head

Locations

Country	Name	City	State
China	Guang'anmen Hospital	Beijing	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences	California Pacific Medical Center Research Institute, Massachusetts General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	psychological questionnaires		12 weeks post treatment.	Yes