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Efficacy Study of Korean Red Ginseng to Treat Depression

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Korean Red Ginseng
Sponsored by
Korea University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major depressive disorder, Residual symptoms, Korean red ginseng

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Sites / Locations

  • Korea University Ansan Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Korean Red Ginseng

Arm Description

Extract of Korean red ginseng was administrated to subjects through capsule form.

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

Visual Analogue Scale
This has been described as simple, highly sensitive, and reliable rating scales for subjective experiences. The VAS in this study is used for assessing of variation in severity of residual symptoms. The subject is asked to indicate his/her perceived symptom severity along a 100 mm horizontal line, and this rating is then measure from the left edge (0, no symptom) to right edge (100, most severe).
Visual Analogue Scale
This has been described as simple, highly sensitive, and reliable rating scales for subjective experiences. The VAS in this study is used for assessing of variation in severity of residual symptoms. The subject is asked to indicate his/her perceived symptom severity along a 100 mm horizontal line, and this rating is then measure from the left edge (0, no symptom) to right edge (100, most severe).
Montgomery Asberg Depression Rating Scale
This is a 10-item depression rating scale, widely used in depressed patients. Each item is rated from 0 to 6. A total score is the range from 0(none) to 60(most severe). The MADRS has been designed to measure severity of depression in clinical samples and be sensitive to change during antidepressant treatment.
Montgomery Asberg Depression Rating Scale
This is a 10-item depression rating scale, widely used in depressed patients. Each item is rated from 0 to 6. A total score is the range from 0(none) to 60(most severe). The MADRS has been designed to measure severity of depression in clinical samples and be sensitive to change during antidepressant treatment.
Clinical Global Index
This was developed for use in psychopharmacology trials and then, it has been expanded in its use as a standard primary measure in studies investigating the efficacy of pharmacological treatments for various psychiatric illnesses such as depression, anxiety disorder, and bipolar disorder. The CGI-S rates the severity of the patient's illness, on a 7-point scale ranging from 1(Normal) 1 to 7(Extremely ill), according to the clinician's experience of patients suffering from the same condition.
Clinical Global Index
This was developed for use in psychopharmacology trials and then, it has been expanded in its use as a standard primary measure in studies investigating the efficacy of pharmacological treatments for various psychiatric illnesses such as depression, anxiety disorder, and bipolar disorder. The CGI-S rates the severity of the patient's illness, on a 7-point scale ranging from 1(Normal) 1 to 7(Extremely ill), according to the clinician's experience of patients suffering from the same condition.

Full Information

First Posted
December 18, 2011
Last Updated
October 6, 2014
Sponsor
Korea University
Collaborators
The Korean Society of Ginseng
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1. Study Identification

Unique Protocol Identification Number
NCT01496248
Brief Title
Efficacy Study of Korean Red Ginseng to Treat Depression
Official Title
The Effect of Korean Red Ginseng as Adjuvant Treatment for the Residual Symptoms of Depression
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korea University
Collaborators
The Korean Society of Ginseng

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 ginseng at doses of 3g / day during 8 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Major depressive disorder, Residual symptoms, Korean red ginseng

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Korean Red Ginseng
Arm Type
Experimental
Arm Description
Extract of Korean red ginseng was administrated to subjects through capsule form.
Intervention Type
Dietary Supplement
Intervention Name(s)
Korean Red Ginseng
Intervention Description
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.
Primary Outcome Measure Information:
Title
Depression Residual Symptom Scale
Description
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).
Time Frame
Baseline
Title
Depression Residual Symptom Scale
Description
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).
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Visual Analogue Scale
Description
This has been described as simple, highly sensitive, and reliable rating scales for subjective experiences. The VAS in this study is used for assessing of variation in severity of residual symptoms. The subject is asked to indicate his/her perceived symptom severity along a 100 mm horizontal line, and this rating is then measure from the left edge (0, no symptom) to right edge (100, most severe).
Time Frame
Baseline
Title
Visual Analogue Scale
Description
This has been described as simple, highly sensitive, and reliable rating scales for subjective experiences. The VAS in this study is used for assessing of variation in severity of residual symptoms. The subject is asked to indicate his/her perceived symptom severity along a 100 mm horizontal line, and this rating is then measure from the left edge (0, no symptom) to right edge (100, most severe).
Time Frame
8 weeks
Title
Montgomery Asberg Depression Rating Scale
Description
This is a 10-item depression rating scale, widely used in depressed patients. Each item is rated from 0 to 6. A total score is the range from 0(none) to 60(most severe). The MADRS has been designed to measure severity of depression in clinical samples and be sensitive to change during antidepressant treatment.
Time Frame
Baseline
Title
Montgomery Asberg Depression Rating Scale
Description
This is a 10-item depression rating scale, widely used in depressed patients. Each item is rated from 0 to 6. A total score is the range from 0(none) to 60(most severe). The MADRS has been designed to measure severity of depression in clinical samples and be sensitive to change during antidepressant treatment.
Time Frame
8 weeks
Title
Clinical Global Index
Description
This was developed for use in psychopharmacology trials and then, it has been expanded in its use as a standard primary measure in studies investigating the efficacy of pharmacological treatments for various psychiatric illnesses such as depression, anxiety disorder, and bipolar disorder. The CGI-S rates the severity of the patient's illness, on a 7-point scale ranging from 1(Normal) 1 to 7(Extremely ill), according to the clinician's experience of patients suffering from the same condition.
Time Frame
Baseline
Title
Clinical Global Index
Description
This was developed for use in psychopharmacology trials and then, it has been expanded in its use as a standard primary measure in studies investigating the efficacy of pharmacological treatments for various psychiatric illnesses such as depression, anxiety disorder, and bipolar disorder. The CGI-S rates the severity of the patient's illness, on a 7-point scale ranging from 1(Normal) 1 to 7(Extremely ill), according to the clinician's experience of patients suffering from the same condition.
Time Frame
8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young-Hoon Ko, M.D., Ph.D.
Organizational Affiliation
Korea University Medical Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korea University Ansan Hospital
City
Ansan
State/Province
Gyeonggi-do
ZIP/Postal Code
425-707
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
25504813
Citation
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.
Results Reference
derived

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Efficacy Study of Korean Red Ginseng to Treat Depression

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