Efficacy Study of Korean Red Ginseng to Treat Depression

This study has been completed.
Sponsor:
Collaborator:
The Korean Society of Ginseng
Information provided by (Responsible Party):
Young-Hoon Ko, Korea University
ClinicalTrials.gov Identifier:
NCT01496248
First received: December 18, 2011
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention
Major Depressive Disorder
Dietary Supplement: Korean Red Ginseng

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Korean Red Ginseng as Adjuvant Treatment for the Residual Symptoms of Depression

Further study details as provided by Korea University:

Primary Outcome Measures:
  • Depression Residual Symptom Scale [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 35
Study Start Date: August 2011
Study Completion Date: December 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Korean Red Ginseng
Extract of Korean red ginseng was administrated to subjects through capsule form.
Dietary Supplement: Korean Red Ginseng
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01496248

Locations
Korea, Republic of
Korea University Ansan Hospital
Ansan, Gyeonggi-do, Korea, Republic of, 425-707
Sponsors and Collaborators
Korea University
The Korean Society of Ginseng
Investigators
Principal Investigator: Young-Hoon Ko, M.D., Ph.D. Korea University Medical Centre
  More Information

No publications provided

Responsible Party: Young-Hoon Ko, Associate Professor, Korea University
ClinicalTrials.gov Identifier: NCT01496248     History of Changes
Other Study ID Numbers: R1105721
Study First Received: December 18, 2011
Results First Received: September 24, 2014
Last Updated: October 6, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Korea University:
Major depressive disorder
Residual symptoms
Korean red ginseng

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on October 21, 2014