Efficacy Study of Korean Red Ginseng to Treat Depression
The Effect of Korean Red Ginseng as Adjuvant Treatment for the Residual Symptoms of Depression
1 other identifier
interventional
35
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable major-depressive-disorder
Started Aug 2011
Shorter than P25 for not_applicable major-depressive-disorder
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 18, 2011
CompletedFirst Posted
Study publicly available on registry
December 21, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedResults Posted
Study results publicly available
October 10, 2014
CompletedOctober 10, 2014
October 1, 2014
11 months
December 18, 2011
September 24, 2014
October 6, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Depression Residual Symptom Scale
This consists of 25 items and includes specific residual depressive symptoms, e.g. sadness and anhedonia, lack of energy, psychomotor retardation and anxiety, as well as items reflecting subjective feelings of vulnerability, loss of internal reference points and increased emotionalism. Patients were instructed to compare the past 7 days with the period before the very first symptoms of the most recent depressive episode. Each item is scored as 0 to 3. A total score is the range from 0(none) to 75(most severe).
Baseline
Depression Residual Symptom Scale
This consists of 25 items and includes specific residual depressive symptoms, e.g. sadness and anhedonia, lack of energy, psychomotor retardation and anxiety, as well as items reflecting subjective feelings of vulnerability, loss of internal reference points and increased emotionalism. Patients were instructed to compare the past 7 days with the period before the very first symptoms of the most recent depressive episode. Each item is scored as 0 to 3. A total score is the range from 0(none) to 75(most severe).
8 weeks
Secondary Outcomes (6)
Visual Analogue Scale
Baseline
Visual Analogue Scale
8 weeks
Montgomery Asberg Depression Rating Scale
Baseline
Montgomery Asberg Depression Rating Scale
8 weeks
Clinical Global Index
Baseline
- +1 more secondary outcomes
Study Arms (1)
Korean Red Ginseng
EXPERIMENTALExtract of Korean red ginseng was administrated to subjects through capsule form.
Interventions
100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- The patients unable/unlikely to comprehend/follow the protocol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Korea Universitylead
- The Korean Society of Ginsengcollaborator
Study Sites (1)
Korea University Ansan Hospital
Ansan, Gyeonggi-do, 425-707, South Korea
Related Publications (1)
Jeong HG, Ko YH, Oh SY, Han C, Kim T, Joe SH. Effect of Korean Red Ginseng as an adjuvant treatment for women with residual symptoms of major depression. Asia Pac Psychiatry. 2015 Sep;7(3):330-6. doi: 10.1111/appy.12169. Epub 2014 Dec 12.
PMID: 25504813DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Young-Hoon Ko
- Organization
- Krea University College of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Young-Hoon Ko, M.D., Ph.D.
Korea University Medical Centre
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
December 18, 2011
First Posted
December 21, 2011
Study Start
August 1, 2011
Primary Completion
July 1, 2012
Study Completion
December 1, 2012
Last Updated
October 10, 2014
Results First Posted
October 10, 2014
Record last verified: 2014-10