Status:
COMPLETED
Efficacy Study of Korean Red Ginseng to Treat Depression
Lead Sponsor:
Korea University
Collaborating Sponsors:
The Korean Society of Ginseng
Conditions:
Major Depressive Disorder
Eligibility:
FEMALE
18-55 years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether Korean Red Ginseng are effective in the treatment of the residual symptoms of depression as an adjuvant treatment.
Detailed Description
Thirty-five female outpatients aging from 18 to 65 years, who were remitted from major depression with residual symptoms (Montgomery Asberg Depression Rating Scale, MADRS ≤ 12), were given Korean red ...
Eligibility Criteria
Inclusion
- Outpatients who met Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for major depressive disorder.
- Those who are in remission, which is defined as a MADRS score 8 on two consecutive visits at a 4-week interval.
- Their primary psychiatric clinician determined that they would benefit from an adjuvant treatment of Korean red ginseng for residual symptoms.
Exclusion
- Those who have a history of substance abuse or dependence within 1 month.
- Those who have clinically significant abnormal laboratory values or any other abnormal baseline laboratory findings considered by psychiatrists to be indicative of conditions that might affect the study results.
- Those who have a past history of hypersensitivity or intolerance to Korean red ginseng.
- Those who participated in clinical trials within 1 month before entering the study entry.
- Those who are pregnant or are breast feeding.
- Those who have a immediate risk of harming self or others or history of suicide attempts in the year before the screening precluded inclusion in the study.
- The patients unable/unlikely to comprehend/follow the protocol.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01496248
Start Date
August 1 2011
End Date
December 1 2012
Last Update
October 10 2014
Active Locations (1)
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1
Korea University Ansan Hospital
Ansan, Gyeonggi-do, South Korea, 425-707